Surgical Technique

LOCKING RECONSTRUCTION PLATEMandibular Modular Fixation System

INTRODUCTION

SURGICAL TECHNIQUE

PRODUCT INFORMATION

TABLE OF CONTENTS

Locking Reconstruction Plate Surgical Technique DePuy Synthes CMF

The Locking Reconstruction Plate Module 2

Clinical Uses 3

Indications 3

Implant Features 4

Technique for Reconstruction and 5 Trauma Indications

Locking Reconstruction Plate Module Set 9 with Titanium Implants (145.401)

An internal fixation system that provides the option of locked or standard screw and plate fixation to achieve stability.• Indicated for trauma or reconstruction applications.• Choice of 2.4 mm and 3.0 mm locking screws

or standard 2.4 mm screws.• Replaces the 2.4 mm Reconstruction

Module and fits into the Mandibular Modular Fixation System.

• Offers low-profile plate and screw design.

• Commercially pure titanium for biocompatibility.

* Plate fracture is possible when a plate bears the entire functional load for an extended period.Implantation of bone graft, immediately or at a later date, is necessary to support the construct.

2 DePuy Synthes CMF Locking Reconstruction Plate Surgical Technique

THE LOCKING RECONSTRUCTION PLATE MODULE

The Locking Reconstruction Plates are intended for:• Mandible trauma and reconstruction procedures

• Primary mandibular reconstruction (use with bone graft)• Temporary bridging with delayed secondary reconstruction*

• Comminuted Fracture

CLINICAL USES

These devices are intended for single use only and may be offered STERILE and/or NONSTERILE.

MR INFORMATIONThis device has not been evaluated for safety and compatibility in the MR environment. This device has not been tested for heating or migration in the MR environment.

* Plate fracture is possible when a plate bears the entire functional load for an extended period. Implantation of bone graft, immediately or at a later date, is necessary to support the construct.

Locking Reconstruction Plate Surgical Technique DePuy Synthes CMF 3

INDICATIONS

4 DePuy Synthes CMF Locking Reconstruction Plate Surgical Technique

Bending inserts are available and may be used for more extensive contouring of the Locking Reconstruction Plate.

Straight

Angled

Double Angled

Low-profile plate design increases the ease of contouring.

Locking Screws• Special double-lead thread beneath the screw head

engages and locks into the threaded holes of the plate.• Color-coding assists in locking screw size identification:

2.4 mm locking screw is purple, the 3.0 mm locking screw is aqua.

Locking Reconstruction Plates• Plate hole design offers both locking or non-locking

options for trauma and reconstruction.• Selection includes various sizes of straight, angled and

double-angled plates.• Varied angled short plates provide increased opportunity

for optimal plate placement.• Threaded plate holes accept both 2.4 mm and 3.0 mm

locking screws for optimal fixation.• Plate hole design also allows use of 2.4 mm standard

screws for greater screw angulation and compression.• Closely spaced holes optimize fixation in minimal bone space.

2.4 mm 2.4 mm 3.0 mm Locking (non-locking) Locking Screw Screw Screw

2.4 mm 3.0 mm

IMPLANT FEATURES

1ExposureExpose the fracture or area to be resected.

2Select the template The template should be the appropriate length to allow for four holes per segment. When using the plate as a bridging device with 2.4 mm locking screws, allow for a minimum of four screws per segment. For instances where limited bone length or poor bone quality exist, a minimum of three 3.0 mm locking screws should be used.

Note: Screws should be at least 1 cm from the fracture or osteotomy.

3Select the implantsSelect the appropriate plate, cut to length if necessary. Determine the appropriate screw type (standard or locking) and screw diameter (2.4 mm or 3.0 mm).

2.4 mm 2.4 mm 3.0 mm Locking Screw (non-locking) Locking Screw Screw

Locking Reconstruction Plate Surgical Technique DePuy Synthes CMF 5

TECHNIQUE FOR RECONSTRUCTION AND TRAUMA INDICATIONS

4Contour the plate Contour the plate to the template. Make final adjustments to match the anatomy. An exact match is not required when using locking screws. Plate stability is not dependent on plate to bone contact when screws are locked.

For trauma indications: Contour the plate to match the template, then make final adjustments to match the anatomy. Locking or non-locking screws may be used.

5Position the plate Place the plate over the area of the defect. Allow for a minimum of four 2.4 mm locking screws on each side of the defect. In cases where minimal bone length exists and four locking screws cannot be inserted on each side of the defect, three 3.0 mm locking screws should be used. In cases of osteoporotic bone, it may be desirable to use four 3.0 mm locking screws.

For trauma indications: Place the plate over the fracture allowing for a minimum of three screws on each side of the defect.

6Drill the first hole For locked screws, it is important that the drill hole be centered in the plate hole, therefore, use the threaded drill guide. Insert the threaded drill guide into the plate hole and drill through the guide.• For 2.4 mm locking screws (purple), use the 1.8 mm drill

bit and a 1.8 mm threaded drill guide.�• For 3.0 mm locking screws (aqua), use the 2.4 mm

drill bit and a 2.4 mm threaded drill guide.

For trauma indications: If using standard 2.4 mm screws, use the 1.8 mm DCU Neutral Drill Guide (397.318).

Precautions• Drill rate should never exceed 1,800 rpm. Higher

rates can result in thermal necrosis of the bone, soft tissue burns, and an oversized hole to be drilled. The adverse effects of an oversized hole include reduced pullout force, increased ease of the screws stripping in bone, and/or suboptimal fixation.

• Always irrigate during drilling.• Avoid drilling over nerve or tooth roots.• Take care while drilling as to not damage, entrap, or

tear a patient’s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials.

• Handle devices with care and dispose worn bone cutting instruments in a sharps container.

6 DePuy Synthes CMF Locking Reconstruction Plate Surgical Technique

Technique for Reconstruction and Trauma Indications

7Measure screw length Use a depth gauge to determine the appropriate screw length.

8Insert the screw Insert the proper length 2.4 mm or 3.0 mm locking screw, or 2.4 mm standard screw, through the plate and tighten until secure.

9Drill and place the remaining screws Drill the second hole on the opposite side of the defect with the proper threaded drill guide and drill bit. Insert the appropriate length screw. Insert all remaining screws alternating to each side of the mandible.

For trauma indications: Using the proper drill guide and drill bit, drill the second hole on the opposite side of the fracture. The plate holes allow full angulation of 2.4 mm screws for lagging large bone fragments. For compression, use standard AO compression plating technique. Insert all remaining screws. (Plate application complete)

Note: Please see Page 6 for Precautions for Drill Bits.

Technique for Reconstruction and Trauma Indications

Locking Reconstruction Plate Surgical Technique DePuy Synthes CMF 7

10 Resect the mandible Once the plate is in place, remove the 2.4 mm or 3.0 mm locking screws and plate. Resect the mandible.

11 Replace the implants Position the plate back onto the mandible in the exact position. Reinsert each predetermined locking screw. Plates may be used to temporarily bridge continuity defects without bone graft, but only with pending secondary reconstruction.*

12 Resection complete Check all screws to ensure a secure fit to the plate. Fixation is now complete.

* Plate fracture is possible when a plate bears the entire functional load for an extended period. Implantation of bone graft, immediately or at a later date, is necessary to support the construct.

Note: For additional information regarding the procedure within this Technique Guide, please refer to the following publication.

J. Prein, ed. Manual of Internal Fixation of the Cranio-Facial Skeleton. Berlin: Springer, 1998.

Technique for Reconstruction and Trauma Indications

8 DePuy Synthes CMF Locking Reconstruction Plate Surgical Technique

304.701 Locking Reconstruction Plate Module306.660 Screw Length Marker Kit for Mandibular

Modular Fixation System Modules

Instruments310.522 1.8 mm Drill Bit, 125 mm, Stryker J-Latch,

3 ea397.441 1.8 mm Threaded Drill Guide, short, for

Locking Reconstruction Plate

310.542 2.4 mm Drill Bit, 125 mm, Stryker J-Latch, 3 ea

397.442 2.4 mm Threaded Drill Guide, short, for Locking Reconstruction Plate

Bending Templates for Locking Reconstruction Plates

329.769 6 x 23 holes, angled329.40.98 37 holes329.402 5 x 22 x 5 holes, double angled

Screws 2.4 mm Titanium Cortex Screws,

self-tapping401.508 8 mm, 2 pkgs401.510 10 mm, 2 pkgs401.512 12 mm, 2 pkgs401.514 14 mm, 2 pkgs401.516 16 mm, 1 pkg401.518 18 mm, 1 pkg

2.7 mm Titanium Emergency Screws401.558E 8 mm, 2 ea401.560E 10 mm, 2 ea401.562E 12 mm, 2 ea401.564E 14 mm, 2 ea401.566E 16 mm401.568E 18 mm

2.4 mm Titanium Locking Screws, for Locking Reconstruction Plate

497.668 8 mm, 2 pkgs497.670 10 mm, 2 pkgs497.672 12 mm, 3 pkgs497.674 14 mm, 3 pkgs497.676 16 mm, 3 pkgs497.678 18 mm, 2 pkgs

3.0 mm Titanium Locking Screws, for Locking Reconstruction Plate

497.690 8 mm, 1 pkg497.691 10 mm, 2 pkgs497.692 12 mm, 3 pkgs497.693 14 mm, 3 pkgs497.694 16 mm, 2 pkgs497.695 18 mm, 1 pkg

Note: 5 screws per pkg

Plates Titanium Locking Reconstruction Plates449.612 12 holes, 96 mm, 3 ea449.621 20 holes, 160 mm, 3 ea

Titanium Locking Reconstruction Plates449.632 6 x 23 holes, left, 44 mm x 214 mm, 2 ea449.633 6 x 23 holes, right, 44 mm x 214 mm, 2 ea

Titanium Locking Reconstruction Plate, double angled449.637 5 x 22 x 5 holes

Also Available497.689 Titanium Bending Insert Screw for Locking Reconstruction Plate (5/pkg)397.218 1.8 mm Threaded Drill Guide, for Locking Reconstruction Plate*397.224 2.4 mm Threaded Drill Guide, for Locking Reconstruction Plate*401.520– 2.4 mm Titanium Cortex Screws, self-tapping, 401.540 20 mm–40 mm lengths, in 2 mm increments

2.4 mm Titanium Locking Screws, for Locking Reconstruction Plate

497.680 20 mm497.682 22 mm497.684 24 mm

3.0 mm Titanium Locking Screws, for Locking Reconstruction Plate

497.696 20 mm497.697 22 mm497.698 24 mm

Titanium Locking Reconstruction Plates, with Condylar Head449.644 3 x 16 holes, right 449.647 4 x 18 holes, left449.645 3 x 16 holes, left 449.648 5 x 20 holes, right449.646 4 x 18 holes, right 449.649 5 x 20 holes, left

Titanium Locking Reconstruction Plates, angled449.651 3 x 3 holes, crescent shape449.652 3 x 3 holes449.653 4 x 4 holes449.654 5 x 8 holes, left449.655 5 x 8 holes, right

Titanium Locking Reconstruction Plates, double angled449.636 4 x 20 x 4 holes449.638 6 x 24 x 6 holes

Bending Templates, double angled329.401 4 x 20 x 4 holes329.403 6 x 24 x 6 holes

For detailed cleaning and sterilization instructions, please refer to:www.synthes.com/cleaning-sterilizationIn Canada, the cleaning and sterilization instructions will be provided with the Loaner shipments.

Locking Reconstruction Plate Surgical Technique DePuy Synthes CMF 9

LOCKING RECONSTRUCTION PLATE MODULE SET WITH TITANIUM IMPLANTS [145.401]

Some devices listed in this Technique Guide may not have been licensed in accordance with Canadian Law and may not be for sale in Canada. Please contact your Sales Consultant for items approved for sale in Canada.

Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

Rx only

Not all products are currently available in all markets.

© DePuy Synthes CMF, a division of DOI 2015. All rights reserved. DSUS/CMF/0914/0205 2/15

Legal Manufacturer (Canada):Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185

Manufactured by (United States):Synthes USA Products, LLC1302 Wrights Lane EastWest Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056www.depuysynthes.com