Resorbable Orthopedic Fixation System

Transcription

1 TM Resorbable Orthopedic Fixation System Made exclusively from Resorbable Copolymer The Resorbable Orthopedic Mesh Panel and Sheet System

2 Resorbable fixation that s as easy as 1 LactoSorb Copolymer 82% L-lactic Acid 18% Glycolic Acid 2 Strength profile that supports healing Significant strength retention through 6 8 weeks Completely resorbed in approximately one year Clinically proven with over 20,000 cases Extensive Range of Implants Maximize Surgical Options 1 Modified from: Pietrzak, W.S. et al., Applied Biomaterials, 38(1): 17 24, Modified from: Rodeo, S.A. et al., JBJS, 75-A(12): , mm solid screws 2.8mm solid screws 3.5 solid and cannulated corticle screws 4.0 cannulated screws 1mm and 2mm thick mesh panels 0.5mm and 1.0mm thick sheets 3Easy-to-Use Instruments Air or water activated heat packs Hex-drive screwdriver Easy screw removal, if necessary Drill and tap guides available

3 General Guidelines for use of the ReUnite Resorbable Mesh Panel & Sheet System Step 1: Select Appropriate Implant Mesh Panel Mesh panels are available in two thicknesses (1.0mm and 2.0mm) and are 75 x 75mm square. Mesh panels are also available with small or large pre-formed countersunk holes. Small holes accommodate both the 2.5 and 2.8mm diameter ReUnite screws. Large holes accommodate both the 3.5mm and 4.0mm diameter ReUnite screws. Figure 1 Sheets Sheets are available in two thicknesses (0.5mm and 1.0mm) and are 50 x 50mm square. The 2.5mm, 2.8mm, 3.5mm, or 4.0mm diameter ReUnite screws can be used (Figure 1). Step 2: Activate Biomet Heat Pack Water Activated Heat Pack Inject 236 cc's of water (8 oz). Shake heat pack and evacuate excess air within the pouch. Water activated heat pack is ready to use immediately (Figure 2a). Figure 2a Air Activated Heat Pack Open packaging, exposing heat pack to air. Shake periodically. Heat pack will reach appropriate temperature in approximately 45 minutes (Figure 2b). Figure 2b

4 General Guidelines for use of the ReUnite Resorbable Mesh Panel & Sheet System Step 3: Heat Mesh Panel/Sheet Place mesh panel/sheet on uninsulated surface of heat pack. Fold heat pack in half to cover implant. Implant will become malleable in approximately seconds (Figure 3). Figure 3 Step 4: Cut Mesh Panel/Sheet to Desired Size Using scissors, or Biomet Heat Loop, cut the mesh panel/sheet to desired size (Figure 4). Note: Implant will cool as it is being cut. It is not necessary for implant to remain warm/malleable while cutting. It is necessary that the implant go through one heating cycle prior to cutting. Figure 4 Step 5: Contour Mesh Panel/Sheet to Desired Shape Reheat implant using Biomet Heat Pack. Upon removal from the heat pack the implant will remain malleable for approximately seconds. Adapt implant to desired shape and hold in place while cooling. Once cool, the implant will retain the new shape (Figure 5). Note: Implant can be heated up to three times, if necessary, to obtain desired shape. Figure 5

5 Step 6: Drill Holes for Screws Insert appropriate drill guide sleeve into guide handle. Drill pilot hole with appropriate drill bit (Figure 6). Figure 6 Screw 2.5mm 2.8mm 3.5mm 4.0mm Drill Bit 2.2mm diameter 2.2mm diameter 3.0mm diameter 3.0mm diameter Step 7: Measure Hole Depth Solid Screws: Use the provided Biomet depth gauge to measure hole depth (Figure 7a). Figure 7a Cannulated Screws: Reference calibrated depth markings on drill bit against proximal end of the drill guide sleeve (Figure 7b). Figure 7b Depth reference

6 General Guidelines for use of the ReUnite Resorbable Mesh Panel & Sheet System Step 8: Tap Insert appropriate tap guide sleeve into guide handle. Tap the entire length of the screw with the appropriate tap (i.e. 2.5mm tap for 2.5mm screw) (Figure 8). Step 9: Insert Screws Insert hex head of screw into socket of driver. Torque screw into tapped bone hole. When the screw is fully seated, an additional turn of the driver will shear off the hex head, leaving the permanent head intact (Figure 9). Note: If the hex head does not shear off, the Biomet Heat Loop should be used to remove the hex head. Step 10: Screw Removal (if necessary) If screw removal is necessary after the hex head has been removed, the screw can be backed out using the appropriate spanner instrument. This instrument should not be used to further tighten the screw (Figure 10). Figure 8 Figure 9 Depth reference Figure 10 Indications for use: The LactoSorb Panels and Fasteners are used in maintaining the position of bony fragments or morselized bone graft in the Iliac crest autograft procedures. This product is not intended for use in the spine or joint space. This product is not intended for pelvic fracture fixation. Biomet, as the manufacturer of this device, does not practice medicine and does not recommend this or any other system for use on a specific patient. The surgeon who performs any procedure is responsible for determining and utilizing the appropriate techniques for such procedure for use on a specific patient. Biomet is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. Biomet, LactoSorb and ReUnite TM are trademarks of Biomet, Inc.

7 2.5mm/2.8mm Screw Instrumentation Small Screwdriver Small Modular Handle Direct Head Driver Sterile Drill Bit mm Sterile Tap mm Sterile Tap Drill Guide mm Drill Sleeve /2.5mm Tap Sleeve mm Tap Sleeve Depth Gauge Instrument Case mm/4.0mm Screw Instrumentation K-Wire 1.4mm inch K-Wire Sleeve Guide Handle mm Solid Sterile Drill Bit mm Cannulated Sterile Drill Bit mm Drill Sleeve mm Cannulated Overdrill Cannulated Countersink "T" Tap Handle Bayonette Tap Handle mm Cannulated Sterile Tap mm Cannulated Sterile Tap mm Tap Sleeve mm Tap Sleeve Screwdriver Spanner Removal Instrument (3.5mm screw) Spanner Removal Instrument (4.0mm screw) Depth Gauge Instrument Case

8 Ordering Information ReUnite 2.5mm Orthopedic Screws Part Number Length Description mm 7mm 9mm 11mm 13mm 15mm 17mm 19mm 21mm 23mm 25mm 27mm Part Number Length Description Part Number Part Number ReUnite 2.8mm Orthopedic Screws 11mm 13mm 15mm 17mm 19mm 21mm 23mm 25mm 27mm 29mm 31mm 33mm ReUnite Mesh Panels Description 1.0 x 75mm Sq Mesh Panel (2.5/2.8 screw) 1.0 x 75mm Sq Mesh Panel (3.5/4.0 screw) 2.0 x 75mm Sq Mesh Panel (2.5/2.8 screw) 2.0 x 75mm Sq Mesh Panel (3.5/4.0 screw) ReUnite Sheets Description 0.5 x 50mm Sq Sheet 1.0 x 50mm Sq Sheet ReUnite 3.5mm Orthopedic Screws Part Number Length Description 10mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 10mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm ReUnite 4.0mm Orthopedic Cancellous Screws Part Number Length Description mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 42mm 46mm 50mm 54mm 58mm, P.O. Box 587, Warsaw, IN Biomet Orthopedics, Inc. All Rights Reserved web site: biomet@biomet.com Y-BMT-724/011502/K