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RAPIDSORB® Rapid Resorbable Fixation System

RAPIDSORB® Rapid Resorbable Fixation System
30Pages

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RAPIDSORB® Rapid Resorbable Fixation System - 1

Specialized Implants and Instruments for Craniofacial Reconstruction DePuy Synthes PART OF THE tie&iMitOIVtdo&'MMm FAMILY OF COMPANIES

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RAPIDSORB® Rapid Resorbable Fixation System - 2

Introduction Basic Science 2 RAPIDSORB Rapid Resorbable Fixation System 4 Surgical Technique Preparation 7 • Compact Water Bath System Assembly 7 • Water Bath System Assembly 12 • Compact Water Bath System Disassembly 18 • Water Bath System Disassembly 19 Product Information Instruments 22 Plate Contouring Systems 26 Instrument Cases and Trays 27 RAPIDSORB® Rapid Resorbable Fixation System Surgical Technique DePuy Synthes 1

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RAPIDSORB® Rapid Resorbable Fixation System - 3

Basic Science The implants of the RAPIDSORB Rapid Resorbable Fixation System are manufactured from 85:15 poly (L-lactide-coglycolide). This copolymer is formed by combining L-lactide and glycolide, which maximizes the advantageous characteristics of each component and provides a material well-suited for craniofacial reconstruction (Figure 1). 85:15 poly (L-lactide-co-glycolide) is a linear, substantially amorphous, random copolymer, and retains approximately 85% of its initial bending strength after 8 weeks (Figure 2). RAPIDSORB Implants resorb in approximately 12 months.1 A significant...

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RAPIDSORB® Rapid Resorbable Fixation System - 4

Intraoperative photos of metopic synostosis reconstruction using RAPIDSORB Rapid Resorbable Fixation System. The RAPIDSORB Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, and screws may be used in non-load-bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas....

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RAPIDSORB® Rapid Resorbable Fixation System - 5

RAPIDSORB Rapid Resorbable Fixation System ® RAPIDSORB Plates The wide assortment of implants in the DePuy Synthes Companies RAPIDSORB Rapid Resorbable Fixation System incorporates a plate design with many features and benefits: • • • • • Beveled edge for reduced palpability Optimized screw recess for low profile Straight-edged design for greater strength Groove identifies top surface Cross-slots between holes facilitate bending Specialized Plating Platforms Preshaped orbital floor plate can be quickly and easily contoured (Figure 1). Contourable mesh permits optimal anatomic conformity...

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RAPIDSORB® Rapid Resorbable Fixation System - 6

RAPIDSORB Rapid Resorbable Fixation System RAPIDSORB Screws Screws • Available in 1.5 mm, 2.0 mm, and 2.5 mm diameters • Cruciform recess allows easy pickup, insertion, and removal • Emergency screws can be placed easily by tapping through the original screw • 2.0 mm screws can be used with 1.5 mm plates as primary or emergency screws Plate/screw profiles Low plate and screw profile minimizes soft-tissue irritation, palpability, and the amount of material to be resorbed. • Implants are available in a range of sizes 0.25 mm thick plate with 1.5 mm screw 0.5 mm thick plate with 1.5 mm screw...

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RAPIDSORB® Rapid Resorbable Fixation System - 7

RAPIDSORB Rapid Resorbable Fixation System RAPIDSORB Rapid Resorbable Fixation Instruments A full line of instrumentation and trays meets the needs of both surgeons and operating room personnel. Customizable instrument trays • Two customizable resorbable fixation instrument trays allow storage of preferred instrument combinations • Translucent lid for visualization of contents • Optional bending template module snaps onto either lid for storage Taps • Available with self-drilling tips • Choice of hex or mini quick coupling • Available in adjustable or fixed stop lengths Mini quick coupling...

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RAPIDSORB® Rapid Resorbable Fixation System - 8

In preparation for contouring resorbable plates, meshes, and sheets, set up Water Bath in advance. There are two DePuy Synthes Companies Water Bath options. The Compact Water Bath System (05.725.010) is used with a Sterile Drape. The Water Bath System (530.509) has a Tray and Sterility Cover that must be sterilized before each use. An optional technique of a Sterile Drape is also available for the Water Bath System. Compact Water Bath System Assembly Compact Water Bath System 05.725.010 Compact Water Bath Sterile Drape Compact Water Bath System setup* The Compact Water Bath System must be...

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RAPIDSORB® Rapid Resorbable Fixation System - 9

Preparation Compact Water Bath System Assembly 2. Fill to PREFILL line Fill the pan basin with approximately 50 mL of room temperature sterile water or sterile saline to the PREFILL Line. 8 DePuy Synthes RAPIDSORB® Rapid Resorbable Fixation System Surgical Technique

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RAPIDSORB® Rapid Resorbable Fixation System - 10

Preparation Compact Water Bath System Assembly 3. Insert sterile drape While using sterile technique, unfold the Sterile Drape to locate the center. Hold the center of the drape over the Compact Water Bath and unfold completely. The entire Compact Water Bath should be covered by the Sterile Drape. Caution: Be careful to maintain drape sterility on the upward-facing side of the drape. The Compact Water Bath and surface under the Compact Water Bath is not sterile. Note: Instructions for inserting the Sterile Drape are also included in the Sterile Drape packaging. RAPIDSORB® Rapid Resorbable...

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RAPIDSORB® Rapid Resorbable Fixation System - 11

Preparation Compact Water Bath System Assembly 4. Fill Press the drape down into the basin with one hand while pouring approximately 450 mL of room-temperature sterile water or sterile saline so that the liquid level is between the MIN line and MAX line. Note: To reduce heat-up time, ensure the Sterile Drape contacts the prefill liquid or walls of the Compact Water Bath basin. 11 DePuy Synthes RAPIDSORB® Rapid Resorbable Fixation System Surgical T

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RAPIDSORB® Rapid Resorbable Fixation System - 12

Preparation Compact Water Bath System Assembly 5. Heat liquid Plug power cord into a grounded power outlet. Switch the Power Switch to the ON position. The blue WARMING indicator on the front of the Compact Water Bath will illuminate, signifying that the liquid is heating up. BLUE WARMING indicator After approximately 15 minutes, the green READY FOR USE indicator will illuminate, signifying that the liquid is heated to 149°F–167°F (65°C–75°C) and is ready for use. The Compact Water Bath will maintain at temperature during operation. If the liquid level drops below the MIN fill line,...

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RAPIDSORB® Rapid Resorbable Fixation System 30Pages

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RAPIDSORB® Rapid Resorbable Fixation System
30Pages