Forerunner™ Plating System - SLIDEBLAST.COM

bone fracture fixation and fixation of bones that have been surgically prepared .... plate from the medial cuneiform or navicular into the 2nd or. 3rd...

36 downloads 46 Views 614KB Size

Recommend Documents


Midfoot Plating System ICP
Synthes (USA). Synthes (Canada) Ltd. To Order: (800) 523-0322. To Order: (800) ... 04.211.232. 5° right. 04.211.233. 5° left. 04.211.234. 10° right. 04.211.235.

Large Fragment Plating System
Insertion of a 4.5 mm Locking Cortical Screw or 5.5 mm Cancellous Screw in a ... Insertion of a 6.5 mm Non-Locking Cancellous Screw into any Plate Hole .

Lapidus Plating System - Orthofix
for the complete list of indications, warnings, precautions, and other important .... medially to avoid the medial dorsal cutaneous nerve. 3. When concomitant .... a successful outcome. The following factors and/or conditions may impact overall.

Large Fragment Plating System
Indications for Use: Fixation of fractures of various long bones such as the: • femur. • tibia. • humerus. The Hybrid Compression Plates are further indicated for.

Proximal Humerus Plating System
Biomet's experience in developing implants for fracture fixation through locked plating technology has been used to design the S3 plate for the management of ...

Acumed Ankle Plating System
The Acumed Ankle Plating System 3 is designed to provide a variety of fixation options for simple fractures of the distal tibia and fibula. Designed in conjunction ...

anatomic locked plating system
Specific instruments designed to fit over F.A.S.T. Guide™ in- serts providing optimum leverage. • Plates can be shaped to match the patient's natural anatomy.

Distal Fibula Plating System
George Haidukewych, M.D.. Orlando Regional Medical Center. Orlando Health, Inc. Orlando, Florida. David M. Huebner, M.D.. Director of Orthopaedic Trauma,.

Midfoot Plating System ICP
2.4 mm/2.7 mm VA-Locking Cuboid Plate, left. 04.211.222. 2.4 mm/2.7 mm VA-Locking Cuboid Plate, right. 04.211.224. 2.4 mm/2.7 mm VA-Locking Mesh Plate,.

VariAxFoot Locked Plating System
reference to the metatarsophalangeal axis and neutral rotation). The cup-shaped surfaces allow any one of these dimensions to be changed without altering.

At Biomet, engineering excellence is our heritage and our passion. For over 25 years, through various divisions worldwide, we have applied the most advanced engineering and manufacturing technology to the development of highly durable systems for a wide variety of surgical applications.

Forerunner™ Plating System

To learn more about this product, contact your local Biomet Sales Representative today.

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website.

Responsible Manufacturer Biomet, Inc. P.O. Box 587 56 E. Bell Drive Warsaw, Indiana 46581-0587 USA ©2013 Biomet Orthopedics • Form No. BMET0354.0 • REV011513

www.biomet.com

Rx only.

Surgical Technique

Forerunner™ Plating System

Contents Introduction..................................................... Page 1 Indications And Contraindications.................. Page 2 System Design Features................................. Page 3 Instrumentation............................................... Page 4 Tray Layout...................................................... Page 8 Relevant Anatomy – Midfoot........................... Page 9 Surgical Technique......................................... Page 10 Surgical Technique For Lisfranc Fractures..... Page 14 Ordering Information....................................... Page 16 Package Insert Information............................. Page 18 Further Information......................................... Page 21

Introduction Implant Rationale The Biomet Forerunner Plating System is a comprehensive plating system designed for fixation of boney pathology for the foot and ankle. The wide range of plates with varying lengths between screw holes, as well as the multiple screw diameters made available to the foot and ankle surgeon provide for unlimited combinations for the unique and complicated boney structure of the foot. In addition, providing non-locking, fixed angle locking and poly-axial locking options provides the surgeon even more choices for fixation of the most complex deformities. The Forerunner Plating System can be used in combination with many other foot and ankle products offered by Biomet Trauma, including screws, Biomet® Vision™ FootRing™ System and XS Rail external fixation systems as well as a wide

Source: Charles Zelen, D.P.M.

range of osteobiologics and bone grafts to achieve optimized foot and ankle reconstruction.

1

Indications And Contraindications INDICATIONS

CONTRAINDICATIONS

The Biomet® Forerunner Plating System is intended for adult

1. Active infection.

or pediatric patients as indicated for pelvic, small and long

2. Patient conditions including blood supply limitations, and

bone fracture fixation and fixation of bones that have been

insufficient quantity or quality of bone.

surgically prepared (osteotomy) for correction of deformity or

3. Patients with mental or neurologic conditions who are

arthrodesis. Indications for use include internal fixation of the

unwilling or incapable of following postoperative care

tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot and forefoot bones.

instructions or materials. 4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation

Specific indications for midfoot/forefoot procedures:

of the device.

1. Treatment of fractures and fracture dislocations of the midfoot/forefoot 2. Malunions 3. Non-unions 4. Joint fusions/arthrodesis 5. Corrective osteotomies for deformities These procedures in the midfoot/forefoot may be indicated as a result of trauma, deformity, osteoarthritis and rheumatoid arthritis. Patient selection factors to be considered include: 1. Need for alignment and stabilization of bone fractures. 2. Ability and willingness of the patient to follow postoperative care instructions until healing is complete. 3. A good nutritional state of the patient. 4. Vascular status of patient.

2

System Design Features Plates And Screws The Forerunner Plating System is a versatile system that allows for constrained and semi-constrained fixation. This low profile system features a one step locking mechanism and a unique open design for intra-operative visualization of the graft. This exclusive locking mechanism features SphereLock ™

Variable Bone Screw 20°

technology that allows for simplified and secure locking. SphereLock Technology As the screw head advances into the recess of the plate, the threads on the bone screw interlock with the threads of the plate. The threads of the plate and the bone screw resemble a sphere. In general, a spherical thread design has the ability to self-center itself. In addition, a unique feature of the Biomet Forerunner Plating System is the Variable Bone Screw. The Variable Bone Screw features a poly-axial head. The head is independent of the screw shaft and creates a 20° cone of angulation. • Titanium alloy provides strength and biocompatibility • Locking and Non Locking options for the surgeon • Fixed and Variable Angle options for screw placement • Multiple screw diameters (4.0mm and 4.75mm) • Screw lengths from 12mm through 50mm • Plating options with 4, 6, 8 hole plates with variable distances between holes to optimize plating selection for the surgeon

Plates Available From 12mm To 66mm In Length • 4-Hole Plate (12mm to 22mm) • 6-Hole Plate (24mm to 42mm) • 8-Hole Plate (44mm to 66mm) • All Plates have a 1.9mm profile

3

Instrumentation

PN 14-401420 Plate Bending Handles

PN 14-401413 AO Screw Inserter Shaft (150mm)

Temporary fixation device attachment for precise placement of plate in the foot and ankle

PN 14-401424 AO Screw Inserter Shaft (80mm)

PN 14-401416 Reducer Sleeve

PN 14-401417 2.5mm Temporary Fixator (Whirlybird)

PN 14-401414 AO Awl Shaft

4

PN 14-401418 Extreme Angle Plate Bender

PN 14-401415 Screw Depth Gauge

PN 14-401419 Mid-Plate Bender

PN 14-401421 Baby Hohman Retractor

PN 14-401422 Baby Bennett Retractor

PN 14-401423 Screw Remover Lag Plate

5

Instrumentation (Continued)

PN 14-401425 Fixed Drill Guide

PN 14-401427 Fixed Drill Guide Tube

PN 14-401426 Variable Drill Guide

PN 14-401428 Variable Drill Guide Tube

6

PN 14-401430 2.0mm x 150mm Drill

PN 14-401434 2.0mm x 230mm Drill

PN 14-401431 2.8mm x 150mm Drill

PN 14-401435 2.8mm x 230mm Drill

7

Tray Layout Instrumentation tray optimized for the foot and ankle surgeon complete with AO compatible handles and specialized instrumentation dedicated to the lower extremity surgeon. Instrument Loaner Kit PN 14-401400 Instrument Sterilization Tray PN 14-401410

See page 16 for Complete Instrument and Implant Set List Implant Loaner Kit PN 14-401401 Implant Sterilization Tray PN 14-401411

4-Hole Forerunner Plate Caddy

6-Hole Forerunner Plate Caddy

Forerunner Screw Caddy

8-Hole Forerunner Plate Caddy

1.6mm x 6” Threaded K-Wires

BioDrive Implant Caddy

8

Relevant Anatomy – Midfoot

Second Metatarsal First Metatarsal

Third Metatarsal Fourth Metatarsal Fifth Metatarsal

Medial Cuneiform Lateral Cuneiform Intermediate Cuneiform Cuboid Navicular

Talus Calcaneous

9

Surgical Technique Step 1 - Surgical Exposure The dissection and surgical exposure are determined by the boney segments to be stabilized and the severity of the deformity. Sufficient exposure for insertion of the plates and screws is recommended unless a percutaneous technique is being utilized. NOTE: Unnecessary tension on the skin and soft tissue structures is not recommended since this may lead to wound dehiscence and breakdown. Step 2 - Deformity Correction

Surgical Exposure of the Lateral Column

Once exposure of the boney segments is obtained, appropriate boney resections are then performed and deformity is then corrected. In some cases, bone grafting may be utilized to assist in achieving optimal correction of deformity. In fusion procedures the surgeon may consider the use of cannulated screws for compression of the boney fragments prior to placing the Forerunner plates into position.

Reduction of Deformity, Placement of Bone Wedge, and Propeller Head™ Screw for Compression Source: Charles Zelen, D.P.M.

10

Step 3 - Preparation Of Forerunner Plate The Forerunner Plating System offers unique Plate Benders (PN 14-401420) that allow for an exact contour of the plate specific for the foot and ankle deformity to be addressed.

Bending of the plate to contour to the boney surface PN 14-401420

Step 4 - Application Of The Forerunner Plate A specialized instrument is included in the system for placement of the Forerunner plate known as the Temporary Fixation Device (PN 14-401416 and PN 14-401417). This instrument will assist the surgeon in exact placement of the plate as well as assist in close adherence of the plate to the bone interphase and prevent prominence of the plate on the surrounding soft tissues. One or two of these devices can be used based on surgeon preference.

Use of the temporary fixation device for plate adherence PN 14-401416 PN 14-401417

to bone Source: Charles Zelen, D.P.M.

11

Surgical Technique (Continued) Step 5 - Placement Of Screws The surgeon may choose non-locking, fixed angle locking or poly-axial locking screws. In addition, the surgeon has the option of the 4.0mm standard or 4.75mm relief screw. The lengths of the screws range in total from 10mm to 50mm. All the screws within the Forerunner Plating System are self drilling and self tapping, however in hard bone the surgeon may choose to drill. A drill guide is available to pre-drill with a specialized Variable Angle Drill Guide (PN 14-401426 or PN 14-401428) for use with the poly-axial locking screws. The variable angle guide should sit firmly into the drill hole to ensure that the screw is not inserted beyond the 20 degree

Use of the Variable Angle Drill Guide

cone of angulation required for achieving locking.

Source: Charles Zelen, D.P.M.

NOTE: In addition, the drill bit is calibrated so that the surgeon can measure directly from the drill bit to prevent the need for use of another measuring device.

A close up view of the variable angle locking screw prior to insertion

12

Placement Of Screws (Continued)

Final insertion of four variable angle locking screws into the Insertion of the variable angle locking screw into the Forerunner plate

medial column with a four-hole Forerunner plate Source: Charles Zelen, D.P.M.

Final insertion of six variable angle locking screws into the lateral column with a six-hole Forerunner plate

13

Surgical Technique For Lisfranc Fractures Introduction

Technique

A plate applied to the plantar (tension) side of the medial

Step 1 - Patient Positioning

midfoot provides a strong, sturdy construct for arthrodesis and ambulation after Lisfranc’s dislocation. The tension

Patients are taken to the operating room and placed in a

side is able to maintain correction over high and repetitive

supine position. Following admission of general anesthesia,

loading, which is ideal for arthrodesis and early ambulation of

cotton padding is placed over the upper thigh of the foot being

neuropathic joints. Research has shown that a plate applied

operated on and a pneumatic thigh tourniquet is applied. The

to the plantar (tension) aspect of the medial midfoot provides

foot is then prepped and draped in the usual sterile manner.

a stronger, sturdier construct than does midfoot fusion with screw fixation.* Studies have also revealed that a plantar plate

Step 2 - Incision 1

allows significantly less initial displacement and maintains stabilization at a much higher load. By maintaining correction

The tourniquet is applied and elevated. Attention is directed to

over high and repetitive loading, the patient should be able to

the Achilles tendon where a linear incision is made over the

ambulate earlier while maintaining arthrodesis.

distal 1/3 of the leg. The tendoachilles lengthening is performed. Approximately 2cm of lengthening is achieved. The paratenon was re-approximated using 3.0 vicryl. The subcutaneous tissue is closed using 3.0 vicryl, skin was closed in a horizontal mattress type stitch using 4.0 nylon. Step 3 - Incision 2 Attention is then directed to the planter medial aspect of the foot. A straight incision is made beginning at the talonavicular joint and extending to the distal one-third of the 1st metatarsal shaft. The incision is deepened via sharp and blunt dissection down to the 1st metatarsal, medial cuneiform, and navicular. A full thickness tissue flap is reflected off of the tarsometatarsal joints.

14

Step 4 - Necrotic Bone Removal

Step 5 - Plate Insertion

Attention is directed to the base of Lisfranc’s articulation.

The Lisfranc’s joint is adducted and held into a plantar flexed

An osteotome is used to remove approximately 1.0cm block

position using two 1.6mm Wires (PN 245020) for temporary

of necrotic bone across Lisfranc’s joint, down to good healthy

fixation. Next, the Forerunner plate is eccentrically loaded and

bleeding bone. If necessary, a second incision can be made

applied to the plantar aspect of the first metatarsal, medial

on the lateral aspect of the foot between the 4th and 5th

cuneiform and navicular.

metatarsals. This incision is deepened down to the base of the metatarsals and cuboid. All necrotic bone from lateral to

One cortical screw is placed outside of the Forerunner plate

medial is removed, completing the resection of neuropathic

in an oblique fashion, seating on the medial wall of the first

bone across Lisfranc’s joint.

metatarsal and aiming at the lateral edge of the navicular. Its length depends on the extension of the debrided region.

The same procedure is performed through the innominate i.e. naviculo-cuneiform joints, depending on the extension

A second cortical screw is inserted outside of the Forerunner

of neuroarthropathy destruction, in order to restore the medial

plate from the medial cuneiform or navicular into the 2nd or

arch of the foot.

3rd metatarsal base. No fixation is used on the 4th and 5th rays. Autogenous cancellous bone might be used to fill any void or space at the arthrodesis site. Step 6 - Wound Closure And Dressing The incisions are then dressed using betadine soaked adaptic, 4 x 4’s, and kling. A dry sterile dressing is applied, followed by a posterior splint or Jones compression dressing.

15

Ordering Information Instruments

Plates (Continued)

Catalog #

Description

Catalog #

Description

14-401410

Instrument Tray

Qty. 1

14-401224

6-Hole Plate - 24mm Length

2

14-401411

Implant Tray

1

14-401226

6-Hole Plate - 26mm Length

2

14-401415

Screw Depth Gauge

1

14-401228

6-Hole Plate - 28mm Length

2

14-401413

AO Screw Inserter Shaft (150mm)

1

14-401230

6-Hole Plate - 30mm Length

2

14-401414

AO Awl Shaft

1

14-401232

6-Hole Plate - 32mm Length

2

14-401418

Extreme Angle Plate Bender

1

14-401234

6-Hole Plate - 34mm Length

2

14-401420

Plate Bending Handles

2

14-401236

6-Hole Plate - 36mm Length

2

14-401425

Drill Guide (Fixed)

1

14-401238

6-Hole Plate - 38mm Length

2

14-401426

Drill Guide (Variable)

1

14-401240

6-Hole Plate - 40mm Length

2

14-401427

Drill Guide Tube (Fixed)

2

14-401242

6-Hole Plate - 42mm Length

2

14-401428

Drill Guide Tube (Variable)

2

14-401421

Baby Hohman

2

14-401344

8-Hole Plate - 44mm Length

2

14-401422

Baby Bennett

2

14-401346

8-Hole Plate - 46mm Length

1

14-401424

AO Screw Inserter Shaft (80mm)

2

14-401348

8-Hole Plate - 48mm Length

2

22894

Small Bone Reducing Forceps

1

14-401350

8-Hole Plate - 50mm Length

1

22896

Large Bone Reducing Forceps

1

14-401352

8-Hole Plate - 52mm Length

2

14-401416

Reducer Sleeve

2

14-401354

8-Hole Plate - 54mm Length

1

22880

AO Ratcheting Handle

2

14-401356

8-Hole Plate - 56mm Length

2

14-401423

Screw Remover Lag Plate

1

14-401358

8-Hole Plate - 58mm Length

1

14-401419

Mid-Plate Bender

1

14-401360

8-Hole Plate - 60mm Length

2

14-401417

Temporary Fixator (Whilybird - 2.5mm)

2

14-401362

8-Hole Plate - 62mm Length

1

14-401430

2.0mm x 150mm Drill

2

14-401364

8-Hole Plate - 64mm Length

2

14-401434

2.0mm x 230mm Drill

1

14-401366

8-Hole Plate - 66mm Length

1

14-401431

2.8mm x 150mm Drill

1

14-401435

2.8mm x 230mm Drill

1

Plates

Qty.

4.0mm Locking Variable Self-Drilling Screws Catalog #

Description

Qty.

14-401512

4.0mm x 12mm

4

Qty.

14-401514

4.0mm x 14mm

4

4-Hole Plate - 12mm Length

2

14-401516

4.0mm x 16mm

8

4-Hole Plate - 14mm Length

2

14-401518

4.0mm x 18mm

8

14-401116

4-Hole Plate - 16mm Length

2

14-401520

4.0mm x 20mm

8

14-401118

4-Hole Plate - 18mm Length

2

14-401522

4.0mm x 22mm

8

14-401120

4-Hole Plate - 20mm Length

2

14-401524

4.0mm x 24mm

8

14-401122

4-Hole Plate - 22mm Length

2

14-401526

4.0mm x 26mm

8

14-401528

4.0mm x 28mm

8

14-401530

4.0mm x 30mm

8

14-401535

4.0mm x 35mm

4

Catalog #

Description

14-401112 14-401114

16

4.0mm Locking Variable Self-Drilling Screws (Continued)

4.0mm Non-Locking Fixed Self-Drilling Screws

Catalog #

Description

Catalog #

Description

14-401540

4.0mm x 40mm

Qty. 4

14-402012

4.0mm x 12mm

2

14-401545

4.0mm x 45mm

0*

14-402014

4.0mm x 14mm

2

14-401550

4.0mm x 50mm

0*

14-402016

4.0mm x 16mm

2

14-402018

4.0mm x 18mm

2

14-402020

4.0mm x 20mm

2

14-402022

4.0mm x 22mm

2

14-402024

4.0mm x 24mm

2

14-402026

4.0mm x 26mm

2

14-402028

4.0mm x 28mm

2

14-402030

4.0mm x 30mm

2

14-402035

4.0mm x 35mm

2

14-402040

4.0mm x 40mm

2

14-402045

4.0mm x 45mm

0*

14-402050

4.0mm x 50mm

0*

* The part is not included in set, but can be ordered separately.

4.75mm Locking Variable Salvage Screws Qty.

Qty.

Catalog #

Description

14-401712

4.75mm x 12mm

0*

14-401714

4.75mm x 14mm

0*

14-401716

4.75mm x 16mm

0*

14-401718

4.75mm x 18mm

0*

14-401720

4.75mm x 20mm

0*

14-401722

4.75mm x 22mm

0*

14-401724

4.75mm x 24mm

0*

14-401726

4.75mm x 26mm

0*

14-401728

4.75mm x 28mm

0*

14-401730

4.75mm x 30mm

0*

14-401735

4.75mm x 35mm

0*

Catalog #

Description

14-401740

4.75mm x 40mm

0*

14-402212

4.75mm x 12mm

0*

14-401745

4.75mm x 45mm

0*

14-402214

4.75mm x 14mm

4

14-401750

4.75mm x 50mm

0*

14-402216

4.75mm x 16mm

0*

14-402218

4.75mm x 18mm

4

14-402220

4.75mm x 20mm

0*

14-402222

4.75mm x 22mm

4

14-402224

4.75mm x 24mm

0*

14-402226

4.75mm x 26mm

4

14-402228

4.75mm x 28mm

0*

14-402230

4.75mm x 30mm

4

14-402235

4.75mm x 35mm

4

14-402240

4.75mm x 40mm

4

14-402245

4.75mm x 45mm

0*

14-402250

4.75mm x 50mm

0*

* The part is not included in set, but can be ordered separately.

4.0mm Locking Fixed Self-Drilling Screws Catalog #

Description

Qty.

14-401612

4.0mm x 12mm

4

14-401614

4.0mm x 14mm

4

14-401616

4.0mm x 16mm

8

14-401618

4.0mm x 18mm

8

14-401620

4.0mm x 20mm

8

14-401622

4.0mm x 22mm

8

14-401624

4.0mm x 24mm

8

14-401626

4.0mm x 26mm

8

14-401628

4.0mm x 28mm

8

14-401630

4.0mm x 30mm

8

14-401635

4.0mm x 35mm

4

14-401640

4.0mm x 40mm

4

14-401645

4.0mm x 45mm

0*

14-401650

4.0mm x 50mm

0*

* The part is not included in set, but can be ordered separately.

4.75mm Non-Locking Fixed Self-Drilling - Salvage Screws Qty.

* The part is not included in set, but can be ordered separately.

* The part is not included in set, but can be ordered separately.

17

Package Insert Information DESCRIPTION Biomet® manufactures a variety of internal fixation devices

CONTRAINDICATIONS

intended to aid in the alignment and stabilization of fractures

1. Active infection.

to the skeletal system. These implantable devices include bone

2. Patient conditions including blood supply limitations, and

screws and bone plates. Instrumentation has been designed specifically for use with each system of implants.

insufficient quantity or quality of bone. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care

MATERIALS Titanium Alloy

instructions or materials. 4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation

INDICATIONS

of the device.

The Biomet® Forerunner Plating System is intended for adult or pediatric patients as indicated for pelvic, small and long

WARNINGS

bone fracture fixation and fixation of bones that have been

Internal fixation devices aid the surgeon in the alignment

surgically prepared (osteotomy) for correction of deformity or

and stabilization of skeletal fractures and provide a means of

arthrodesis. Indications for use include internal fixation of the

fracture management in reconstructive surgical applications.

tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna,

While these devices are generally successful in attaining these

radius, middle hand and middle foot and forefoot bones.

goals, they cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial

Specific indications for midfoot/forefoot procedures:

weight bearing or load bearing, particularly in the presence of nonunion, delayed union, or incomplete healing. Metallic bone

1. Treatment of fractures and fracture dislocations of the midfoot/forefoot

fixation devices are internal splints that align the fracture until normal healing occurs. The size and shape of bones and soft

2. Malunions

tissue place limitations on the size and strength of implants. If

3. Non-unions

there is delayed union or nonunion of bone in the presence of

4. Joint fusions/arthrodesis

weight bearing, or load bearing, the implant could eventually

5. Corrective osteotomies for deformities

break. Therefore, it is important that immobilization (use of external support, walking aids, braces, etc.) of the fracture site

These procedures in the midfoot/forefoot may be indicated as

be maintained until firm bony union (confirmed by clinical and

a result of trauma, deformity, osteoarthritis and rheumatoid

radiographic examination) is established. Surgical implants are

arthritis.

subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient’s weight, activity level,

Patient selection factors to be considered include:

and adherence to weight bearing or load bearing instructions

1. Need for alignment and stabilization of bone fractures.

have an effect on the service life of the implant. The surgeon

2. Ability and willingness of the patient to follow postoperative

must be thoroughly knowledgeable not only in the medical and

care instructions until healing is complete. 3. A good nutritional state of the patient.

surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants.

4. Vascular status of patient.

18

1. Correct selection of the implant is extremely important. The potential for success in fracture fixation is

Adequate postoperative management to avoid refracture should follow implant removal.

increased by the selection of the proper type of implant.

6. Adequately instruct the patient. Postoperative care is

While proper selection can help minimize risks, the size

important. The patient’s ability and willingness to follow

and shape of human bones present limitations on the size

instruction is one of the most important aspects of

and strength of implants. Internal fixation devices cannot

successful fracture management. Patients with senility,

withstand the activity levels and/or loads equal to those

mental illness, alcoholism, and drug abuse may be at

placed on normal healthy bone. These devices are not

higher risk. These patients may ignore instructions and

designed to withstand the unsupported stress of full weight

activity restrictions. The patient is to be instructed in the

bearing, or load bearing.

use of external supports, walking aids, and braces that

2. The devices can break when subjected to increased loading

are intended to immobilize the fracture site and limit

associated with nonunion or delayed union. Internal fixation

weight bearing or load bearing. The patient is to be made

devices are load-sharing devices that hold a fracture in

fully aware and warned that the device does not replace

alignment until healing occurs. If healing is delayed, or

normal healthy bone, and that the device can break, bend

does not occur, the implant can be expected to break,

or be damaged as a result of stress, activity, load bearing,

bend or fail. Loads produced by weight bearing, and activity

or weight bearing. The patient is to be made aware and

levels may dictate the longevity of the implant.

warned of general surgical risks, possible adverse effects,

3. Implant materials are subject to corrosion. Implanting

and to follow the instructions of the treating physician.

metals and alloys subjects them to constant changing

The patient is to be advised of the need for regular

environments of salts, acids, and alkalis that can cause

postoperative follow-up examination as long as the device

corrosion. Putting dissimilar metals and alloys in contact

remains implanted.

with each other can accelerate the corrosion process that may enhance fracture of implants. Every effort should be made to use compatible metals and alloys when marrying them to a common goal, i.e., screws and plates.

7. In pediatric patients, care should be taken to avoid the growth plate during plate/screw insertion. 8. Patient smoking may result in delayed healing, non-healing and/or compromised stability in or around the placement site.

4. Correct handling of implants is extremely important. Do not modify implants. Do not notch or bend implants. Notches or

PRECAUTIONS

scratches put in the implant during the course of surgery

Device is single use only.

may contribute to breakage. Intraoperative fracture of screws can occur if excessive force (torque) is applied while seating bone screws. 5. Remove after fracture has healed. Implants can loosen,

Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant.

fracture, corrode, migrate, or cause pain. If an implant remains

Do not treat patients with implants that have been even

implanted after complete healing, the implant may cause

momentarily placed in a different patient.

stress shielding, which may increase the risk of refracture in an active patient. The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.

Instruments are available to aid in the accurate implantation of internal fixation devices. Intraoperative fracture or breaking of instruments has been reported.

19

Package Insert Information (Continued) Surgical instruments are subject to wear with normal usage.

2. The non-sterile system must be sterilized prior to use. All

Instruments which have experienced extensive use or excessive

packaging materials must be removed prior to sterilization. All

force are susceptible to fracture. Surgical instruments

components should be sterilized in a loosened state such that

should only be used for their intended purpose. Biomet

components may move freely.

recommends that all instruments be regularly inspected for wear and disfigurement.

3. Re-sterilization of sterile products which have been opened is permissible as long as the components have not been previously

All trial, packaging, and instrument components must be

implanted, not been exposed to biological contamination, nor

removed prior to closing the surgical site. Do not implant.

appear to have compromised mechanical integrity.

POSSIBLE ADVERSE EFFECTS

The following steam sterilization parameters are recommended:

1.

Nonunion or delayed union, which may lead to breakage of the implant.

Pre-Vacuum Steam Sterilization:

2.

Bending or fracture of the implant.

Temperature:

270°F (132°C)

3.

Loosening or migration of the implant.

Time:

Eight (8) Minutes

4.

Metal sensitivity, or allergic reaction to a foreign body.

Drying Time:

Twenty (20) Minutes

5.

Decrease in bone density due to stress shielding.

NOTE:

Allow for Cooling

6.

Pain, discomfort, or abnormal sensation due to the presence of the device.

Individuals or hospitals not using the recommended method,

7.

Nerve damage due to surgical trauma.

temperature, and time are advised to validate any alternative

8.

Necrosis of bone.

methods or cycles using an approved method or standard.

9.

Postoperative bone fracture and pain.

10.

Inadequate healing.

11. Early

or

late

CAUTION: Federal law (USA) restricts this device to sale by or on postoperative

infection

and/or

the order of a physician.

allergic reaction. MAGNETIC RESONANCE (MR) STATEMENT The effects of the MR environment have not been determined for this device. This device has not been tested for heating or migration in the MR environment. STERILITY

Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet Inc., P.O. Box 587, Warsaw, IN 46581 USA, FAX: 574-372-3968. All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.

The Forerunner Plating System is provided in both sterile and non-sterile configurations. 1. The sterile system is provided sterile using a minimum dosage of 2.5 megaRad (25 kGy) of gamma radiation. Where specified, do not use implants after expiration date.

20

Further Information This brochure describes a surgical technique used by Charles Zelen, D.P.M. and Larry Didominico, D.P.M. Biomet Trauma as the manufacturer of this device, does not recommend this product or any specific surgical technique for use on any individual patient. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. The contents of this manual are intended to be only a guide and are not intended to set a standard of care. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. For further information, please contact the Customer Service Department at: Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 800.348.9500 x 1501 www.biomet.com

21

Notes:

22

Notes:

23

Notes:

24

Life Enjoy

" Life is not a problem to be solved but a reality to be experienced! "

Get in touch

Social

© Copyright 2013 - 2019 DOKUMENTIX.COM - All rights reserved.