Large External Fixator Modular Knee Bridge. Using multi-pin clamps.

Transcription

1 Large External Fixator Modular Knee Bridge. Using multi-pin clamps. Technique Guide Part of the Large External Fixation System

2 Large External Fixator Modular Knee Bridge Technique Overview Insert Schanz screws Use the 6-Position Drill Guide Handle ( ) or multi-pin clamp technique to ensure proper pin spacing. 2 2 Attach multi-pin clamps Tighten vise plates. 3 3 Snap in carbon fiber rods Attach a long carbon fiber rod to each clamp, with ends overlapping. 4 4 Connect carbon fiber rods Snap together with a combination clamp. 5 Reduce fracture Reduce fracture and tighten all clamps. 3 2 Large External Fixator Modular Knee Bridge Technique Guide

3 Recommended Components for Basic Frame Product Item Quantity Number Needed x 5.0 mm Titanium Self-Drilling 4 Schanz Screw Large Multi-Pin Clamp 2 6 position Large Combination Clamp 394.8x.0 mm Carbon 2 Fiber Rod Protective Cap, 4 for.0 mm Rods Protective Cap, for 5.0 mm 4 Fixation Pins MRI Conditions MR Conditional devices have been tested for safety in an MR environment. The MR environment is described as the general environment present in the vicinity of an MR scanner and/or anywhere in the procedure room, including the center of the bore of the MR scanner. Testing was performed to determine displacement force, torque and RF heating induced in devices by the magnetic field of the MR scanner. Testing was performed in compliance with ASTM F2052, ASTM F223 and ASTM F282. Induced displacement force was measured in 3.0 T active shielded MR scanners at a maximum spatial gradient of 45 mt/cm. The measured value was found to be lower than the acceptable limit established by ASTM F2052. Induced torque was measured in a 3.0 T active shielded MR scanner, and the measured value was found to be lower than the acceptable limit established by ASTM F223. Testing for RF heating per ASTM F282 was performed, and the measured value was found to be lower than the acceptable limit when normalized to an SAR of 2.0 W/kg. Field conditions Limits.5 T Scanner 3 T Scanner Field strength (T).5 3 SAR value (W/kg) db/dt (T/sec) Note: The above field conditions should be compared with those of the user s MR system in order to determine if the item can safely be brought into the user s MR environment. If placed in the bore of the MR scanner during scanning, MR Conditional External Fixation devices may have the potential to cause artifact in the diagnostic imaging. WARNINGS All components of External Fixation frames must be identified as MR Conditional prior to being placed in or near an MR environment.

4 Large External Fixator Modular Knee Bridge When to use This frame may be used as a temporary stabilizer for intraarticular fractures of the distal end segment of the femur and the proximal end segment of the tibia. Pin placement To avoid the risk of contamination, Schanz screws should be placed out of the proposed future operative site. 2 Multi-pin clamp technique Insert first Schanz screw Insert Schanz screw through the drill sleeve and end position of the Large Multi-Pin Clamp ( ), using the clamp as an insertion guide. Note: The clamp should be parallel, and the Schanz screws perpendicular, to the bone. 2 Insert second Schanz screw Insert second Schanz screw through the opposite end of the clamp. Tighten vise plates. Note: Additional Schanz screws may be inserted as needed. Schanz screw is perpendicular to bone Rod-clamping nut Rod attachment tightening point Vise plate tightening point Clamp is parallel to bone Stargrind cover: remove to add Rod Attachment for Large Multi-Pin Clamp ( ) References Behrens, F. and K. Searls. External Fixation of the Tibia. Journal of Bone and Joint Surgery 68-B (986): Fernández, A. Modular External Fixation in Emergency using the A.O. Tubular System. Montevideo, Uruguay; Editorial Mar Adentro. Large External Fixator Modular Knee Bridge Technique Guide

5 Optional Frame Configuration Enhancing the frame for additional stability Construct medial frame Connect multi-pin clamps with two carbon fiber rods and a combination clamp on the medial side. 2 Connect rod attachments Thread a rod attachment into each of the multi-pin clamps. 3 Construct lateral frame Construct frame on the lateral side using a combination clamp and two carbon fiber rods. Tighten all clamps.

6 Large External Fixator Set with Self-Drilling Schanz Screws Stainless Steel (5.720) or Titanium (5.740) Graphic Case Large External Fixator Graphic Case Implants in Set (MR Conditional) mm Steinmann Pin with Central Thread, 200 mm, 4 ea mm Schanz Screw, blunted trocar point, 200 mm, 8 ea. 5.0 mm Self-Drilling Schanz Screws, mm, 4 ea mm, 8 ea mm, 8 ea mm Transfixation Pin, 225 mm, MR Conditional, 4 ea. Implants in Set (MR Conditional) mm Steinmann Pin with Central Thread, 200 mm, 4 ea mm Schanz Screw, blunted trocar point, 200 mm, 8 ea mm Transfixation Pin, 225 mm, 4 ea. 5.0 mm Titanium Self-Drilling Schanz Screw mm, 4 ea mm, 8 ea mm, 8 ea. Instruments (for both sets) mm Drill Bit, quick coupling, 95 mm, 2 ea mm Drill Bit, quick coupling, 95 mm, 2 ea Ratchet Wrench, mm width across flats, 2 ea Cannulated Socket Wrench mm/6.0 mm Threaded Drill Sleeve, short mm/6.0 mm Threaded Drill Sleeve, long Position Drill Guide Handle Universal Chuck with T-Handle Drive Adaptor with quick coupling, for 5.0 mm Schanz Screws Drive Adaptor with quick coupling, for 6.0 mm Schanz Screws Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or to the below listed inserts, which will be included in the shipping container: Processing Reusable Medical Devices Instruments, Instrument Trays and Graphic Cases DJ305 Processing Non-sterile Implants DJ304 Large External Fixator Modular Knee Bridge Technique Guide

7 Instruments (for both sets) continued Split Tissue Protection Sleeve, 5.0 mm Open Compressor, 2 ea mm Trocar, short mm Trocar, long Drill Sleeve Handle mm/3.5 mm Drill Sleeve, short mm/3.5 mm Drill Sleeve, long mm/ 5.0 mm Threaded Drill Sleeve, short mm/ 5.0 mm Threaded Drill Sleeve, long Fixation Material (for both sets) (MR Conditional) Large Multi-Pin Clamp, 6 position, 4 ea Rod Attachment, for Large Multi-Pin Clamp, 6 ea Large Multi-Pin Clamp, 4 position, 2 ea Large Combination Clamp, 2 ea Dynamization Clip, for Large Combination Clamp, 4 ea Tube-to-Tube Clamp, 2 ea Large Open Adjustable Clamp, 8 ea * Transverse Clamp, 2 ea..0 mm Carbon Fiber Rods, 4 ea mm mm mm mm mm mm mm Protective Caps For.0 mm Rods, pkg. of For 5.0 mm Fixation Pins, pkg. of For 6.0 mm Fixation Pins, pkg. of 0 *This item has not been tested for use in the MR environment.

8 Also Available Implants (MR Conditional) Schanz Screws mm, spade point, 60 mm 50 mm mm, blunted trocar point, 00 mm 250 mm mm, blunted trocar point, 80 mm 200 mm Self-Drilling Schanz Screws mm, 60 mm 75 mm mm, 00 mm 250 mm mm, 00 mm 250 mm Titanium Self-Drilling Schanz Screws mm, 60 mm 75 mm mm, 00 mm 250 mm mm, 00 mm 250 mm S Fixation Material* Spring-Loaded Nut Adjustable Clamp Open Clamp Universal Joint for Two Tubes Universal Clamp Protective Caps For 4.0 mm Fixation Pins (0/pkg.) For 4.5 mm Fixation Pins (0/pkg.) Sterile-Packaged Large External Fixator Kits S Large External Fixator Ankle Frame Kit, sterile S Large External Fixator Trauma Kit, sterile S Large External Fixator Pelvic Frame Kit, sterile *This item has not been tested for use in the MR environment. Large External Fixator Modular Knee Bridge Technique Guide

9 Sets Power Drive Set 50.6 ComPact Air Drive II Set Accessories for Graphic Case Label Sheet Pack, for Large External Fixator Clamps Label Sheet Pack, for Schanz Screws Replacement Brackets (3 sizes) Replacement Screws (0/pkg.) Label Sheet, for Large External Fixator clamps

10 302 Wrights Lane East West Chester, PA 9380 Telephone: (60) To order: (800) Fax: (60) (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) , Inc. or its affiliates. All rights reserved. is a trademark of, Inc. or its affiliates. Printed in U.S.A. 4/ J335-G