Resorbable Orthopedic Fixation System

Transcription

1 TM Resorbable Orthopedic Fixation System Made exclusively from Resorbable Copolymer The ReUnite Orthopedic 2.0mm Plating System

2 Resorbable fixation that s as easy as 1LactoSorb copolymer 82% L-lactic acid 18% glycolic acid 2 Strength profile that supports healing. Completely resorbed in about one year. Clinically proven with over 20,000 cases. Extensive Range of Implants Maximize Surgical Options Geometric plates 2.0mm diameter screws 2.5mm diameter screws 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): , Easy-to-Use Instruments Hex-drive screwdriver Color-coded drill bits/taps Heat Pack options to soften plates to aid in shaping

3 General Instructions For Fracture Plating Using the ReUnite Orthopedic Plates and Screws. Select appropriate ReUnite plate. (Figure 1) Figure 1 Adapt plate to bone. Heat plate using Biomet air-activated or water-activated heat pack. Place heated plate against bone or pre-bent metal template for approximatley 5 10 seconds, until cool, to retain shape. Ensure countersunk holes are facing away from bone or template surface (Figure 2). Figure 2 Drill holes for screws. A 1.7mm diameter drill bit (red band) is used to form the pilot hole for the 2.0mm diameter screw. A 2.2mm diameter drill bit (silver band) is used to drill the pilot hole for the 2.5mm diameter screw (Figure 3). Figure 3 Measure hole depth. Use the provided depth gauge to measure hole depth. The nominal length of the screw, as labeled, includes the head thickness. The included depth gauge is calibrated to account for this (Figure 4). Figure 4

4 Tap. Tap the hole with the appropriate tap corresponding to the ReUnite screw diameter, i.e., the 2.0mm tap (red band) or the 2.5mm diameter tap (silver band). Figure 5 Note: The hole must be fully tapped the entire threaded length of the screw (Figure 5). Torque screw into hole. Insert hex head of screw into socket of driver and torque into hole. When the screw is fully seated, an additional turn of the driver will shear off the hex head, leaving the low-profile head intact. The spent hex head may be ejected from the driver by pushing the driver handle (Figure 6). Figure 6 If necessary, screw can be removed using the direct head driver (Figure 7). Repeat Steps 1 6 to obtain desired fixation. Figure 7 *Clinical images depict Dr. Jeffrey Visotsky's fixation of a metacarpal fracture using a ReUnite Orthopedic Plate. Instructions For Activation of the Biomet Water-Activated Heat Pack Inject water. Connect sryinge to port and inject 236ml (8 fluid ounces) of sterile water. Figure 8 Mix. Leaving syringe connected to port, gently rock or invert the Heat Pack for approximatley one minute. After mixing, withdraw heated air into syringe and disconnect syringe. Heat Pack should be at operating temperature (Figure 8).

5 Heat ReUnite Plate. Place ReUnite plate on uninsulated surface of heat pack. Fold heat pack to cover the plate. Plate will become malleable within approximately 30 seconds (Figure 9). Figure 9 Adapt ReUnite Plate. Upon removal from the heat pack, heated ReUnite plate will remain malleable for approximately 10 seconds, during which time it can be adapted to the desired shape. As it cools, it will retain the new shape. Figure 10 If desired plate shape is not obtained the plate can be returned to heat pack and reheated. Up to three heating cycles can be performed. Note: The water-activated heat pack should be kept folded (closed) and covered with sterile towels as much as possible to minimize heat loss. In this manner, the heat pack should remain effective for about 30 minutes. Instructions For Activation of the Biomet Air-Activated Heat Pack Activate heat pack. Remove air-activated heat pack from its sterile package and gently shake for approximately one minute. Place unit on sterile table and allow 30 minutes to attain operating temperature. The unit should remain at operating temperature for a minimum of four hours. Figure 11 Heat and adapt ReUnite plate. This is performed similar to the procedure using the water-activated heat pack. Note: Activate air-activated heat pack at least 30 minutes prior to clinical usage. There is no need to cover with sterile towels to retain heat as heat is generated from reaction of heat pack contents with air.

6 Ordering Information Part Number ReUnite 2.0mm Orthopedic Screws Part Number Length Description 5mm 7mm 9mm 11mm 13mm 15mm 17mm ReUnite 2.5mm Orthopedic Screws Part Number Length Description 5mm 7mm 9mm 11mm 13mm 15mm 17mm 19mm 21mm 23mm 25mm 27mm ReUnite Orthopedic Plates Description 6 Hole Wide Plate 4 Hole Straight Plate 6 Hole Straight Plate 6 Hole Extended Straight Plate 7 Hole Y Plate Small Screwdriver Small Modular Handle Direct Head Driver Drill Bit mm mm Tap mm mm Drill Sleeve mm mm Tap Sleeve Small Depth Gauge Water Activated Heat Pack Air Activated Heat Pack Heat Loop Hole Wide Plate Template Hole Straight Plate Template Hole Straight Template Hole Extended Straight Plate Template Hole Y Plate Template Implant Case Instrument Case 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. P.O. Box 587, Warsaw, IN Biomet Orthopedics, Inc. All Rights Reserved web site: biomet@biomet.com Form No. Y-BMT-659/022900/K