Large External Fixator—Modular Knee Bridge. Using multi ...

1 Large External Fixator ModularKnee bridge . Using multi -pin GuidePart of theLarge ExternalFixationSystemSynthesLarge External Fixator modular knee bridge Technique GuideLarge External Fixator modular knee BridgeSynthes Large External Fixation devices are labeled MR Conditional according to the terminology specified in ASTMF2503-08, Standard Practice for Marking Medical Devicesand Other Items for Safety in the Magnetic Resonance testing demonstrated that, when used in the specific configurations stated in Synthes labeling, SynthesLarge External Fixation devices are MR Conditional. Repre-sentative Synthes Large External Fixation devices used in a typical construct include clamps, rods and various patient with a Synthes Large External Fixation frame maybe scanned safely after placement of the frame under thefollowing conditions. Static magnetic field of the fixatorframe is positioned outside the MRI bore at Normal Operator or in First Level Control Mode.

2 Static magnetic field of the fixatorframe is positioned outside the MRI bore at Normal Operator or in First Level Control Mode. Highest spatial gradient magnetic fieldof 720-Gauss/cm or less Maximum MR system reportedwhole body averaged specific absorption rate (SAR) of 2 W/kg for the NormalOperating Mode and 4 W/kg for the First Level ControlledMode for 15 minutes of scanning Use only whole body RF transmit coil, no other trans-mit coils are allowed, local receive only coils are allowed Specialty Coils, such as knee or head coils, should not beused as they have not been evaluated for RF heating andmay result in higher localized :In non-clinical testing, the Synthes External Fixation Deviceswere tested in several different configurations. This testingwas conducted with the construct positioned at the edge ofthe MRI bore, with the entire construct outside the MRI bore. The results showed a maximum observed heating for awrist fixator frame of less than 4 C for and less than 2 C for with a machine reported whole body averaged SAR of 2 W/kg The results showed a maximum observed heating for apelvic frame less than 1 C for and with a machinereported whole body averaged SAR of 2 W/kgPatients may be safely scanned in the MRI chamber at theabove conditions.

3 Under such conditions, the maximal expected temperature rise is less than 6 C. Because higher invivo heating cannot be excluded, close patient monitoringand communication with the patient during the scan is required. Immediately abort the scan if the patient reportsburning sensation or pain. To minimize heating, the scantime should be as short as possible, the SAR as low aspossible, and the device should be as far as possible from theedge of the bore. Temperature rise values obtained werebased upon a scan time of 15 above field conditions should be compared with those ofthe user s MR system, to determine if the item can safely bebrought into the user s MR environment. If placed in the boreof the MR scanner during scanning, Synthes MR Conditionalexternal fixation devices may have the potential to cause artifact in the diagnostic components of Synthes External fixation frames must beidentified as MR Conditional prior to being placed in or nearan MR informationMR image quality may be compromised if the area of interestis in the same area or relatively close to the position of theSynthes Large External Fixation construct, and it may benecessary to optimize MR imaging parameters, to compen-sate for the presence of the fixation devices used to assemble a typical SynthesLarge External Fixation frame have been evaluated in the MRIchamber and worst-case artifact information is provided below.

4 Overall, artifacts created by Synthes Large ExternalFixation devices may present issues if the MR imaging area of interest is in or near the area where the fixation frame is and MRI InformationIndications The Synthes Large External Fixation Systems is intended toprovide treatment for long bone and pelvic fractures that require External fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures Polytrauma/multiple orthopaedic trauma Vertically stable pelvic fractures, or as a treatment adjunctfor vertically unstable pelvic fractures Arthrodesis and osteotomies with soft tissue problems;failures of total joints Neutralization of fractures stabilized with limited internalfixation Non-unions/septic non-unions Intraoperative reductions/stabilization tool to assist withindirect reduction Unilateral rectilinear bone segment transport or leg lengtheningSynthes For FFE sequence: Scan duration: 3 min, TR 100 ms, TE 15 ms, flip angle 15 and SE sequence: Scan duration.

5 4 min, TR 500 ms, TE 20 ms, flip angle 70 radio echo sequence, worst-case artifact will extend approximately 5 cm from the Do not place any radio frequency (RF) transmit coils overthe External fixation External Fixator modular knee bridge Technique GuideLarge External Fixator modular knee Bridge1 Insert Schanz screwsUse the 6-Position Drill Guide Handle ( ) or multi -pin clamp technique to ensure proper pin multi -pin clamps Tighten vise in carbon fiber rodsAttach a long carbon fiber rod to each clamp, with ends carbon fiber rods Snap together with a combination fractureReduce fracture and tighten all Overview113431122 SynthesRecommended Components for Basic FrameProductItemQuantity mm Titanium Self-Drilling 4 Schanz mm Carbon2 Fiber Cap, 4for mm Cap, for mm 4 Fixation multi -Pin Clamp 26 Combination1 ClampSynthesLarge External Fixator modular knee bridge Technique GuideWhen to use This frame may be used as a temporary stabilizer for intra-articular fractures of the distal end segment of the femurand the proximal end segment of the placement To avoid the risk of contamination.

6 Schanz screws should be placed out of the proposed future operative clamp technique1 Insert first Schanz screwInsert Schanz screw through the drill sleeve and end positionof the Large multi -Pin Clamp ( ), Using the clamp asan insertion :The clamp should be parallel, and the Schanz screwsperpendicular, to the second Schanz screwInsert second Schanz screw through the opposite end of theclamp. Tighten vise :Additional Schanz screws may be inserted as , F. and K. Searls. External Fixation of the Tibia. Journal of Bone and Joint Surgery68-B (1986) ndez, A. modular External Fixation in Emergency Using the Tubular System. Montevideo, Uruguay; Editorial Mar Adentro. Large External Fixator modular knee Bridge12 Clamp is parallelto boneSchanz screw is perpendicularto boneRod-clampingnutVise platetightening pointRod attachmenttightening pointStargrind cover: remove to add Rod Attachment for Large multi -Pin Clamp( )SynthesEnhancing the frame for additional stability1 Construct medial frame Connect multi -pin clamps with two carbon fiber rods and a combination clamp on the medial rod attachmentsThread a rod attachment into each of the multi -pin lateral frameConstruct frame on the lateral side Using a combinationclamp and two carbon fiber rods.

7 Tighten all Frame ConfigurationSynthesLarge External Fixator modular knee bridge Technique GuideLarge External Fixator Set With Self-Drilling Schanz ScrewsStainless Steel ( ) or Titanium ( )Graphic Large External Fixator Graphic CaseImplants in Set , MR Conditional mm Steinmann Pin with Central Thread, 200 mm, 4 mm Schanz Screw, blunted trocar point, 200 mm, 8 mm Self-Drilling Schanz mm thread/150 mm, 4 mm thread/175 mm, 8 mm thread/200 mm, 8 mm Transfixation Pin, 225 mm, 4 in Set , MR Conditional mm Steinmann Pin with Central Thread, 200 mm, 4 mm Schanz Screw, blunted trocar point, 200 mm, 8 mm Transfixation Pin, 225 mm, 4 mm Titanium Self-Drilling Schanz mm thread/150 mm, 4 mm thread/175 mm, 8 mm thread/200 mm, 8 (for both sets) mm Drill Bit, quick coupling, 195 mm, 2 mm Drill Bit, quick coupling, 195 mm, 2 Ratchet Wrench, 11 mm width across flats, 2 Cannulated Socket mm / mm Threaded Drill Sleeve, mm / mm Threaded Drill Sleeve, Drill Guide Universal Chuck with Adaptor with quick coupling, for mm Schanz Adaptor with quick coupling, for mm Schanz ScrewsFor detailed cleaning and sterilization instructions, please refer to.

8 In Canada, the cleaning and sterilization instructions will be provided with the Loaner (for both sets) Split Tissue Protection Sleeve, Compressor, 2 mm Trocar, mm Trocar, Sleeve mm / mm Drill Sleeve, mm / mm Drill Sleeve, mm / mm Threaded Drill Sleeve, mm / mm Threaded Drill Sleeve, longFixation Material (for both sets), MR multi -Pin Clamp, 6 position, 4 Attachment, for Large multi -Pin Clamp, 6 Large multi -Pin Clamp, 4 position, 2 Combination Clamp, 12 Clip, for Large CombinationClamp, 4 Clamp, 2 Open Adjustable Clamp, 8 * Transverse Clamp, 2 mm Carbon Fiber Rods, 4 100 250 300 350 400 mmProtective *For mm Rods, (10/pkg.) * For mm Fixation Pins, (10/pkg.) * For mm Fixation Pins, (10/pkg.) *This item has not been tested for use in the MR External Fixator Set With Self-Drilling Schanz ScrewsStainless Steel ( ) or Titanium ( ) continuedAlso AvailableImplants, MR ConditionalSchanz.

9 48 mm, spade point, 60 mm 150 .57 mm, blunted trocar point,100 mm 250 .76 mm, blunted trocar point, 80 mm 200 mmSelf-Drilling Schanz .779 mm, 60 mm 175 .788 mm, 100 mm 250 .798 mm, 100 mm 250 mmTitanium Self-Drilling Schanz .779 mm, 60 mm 175 .788 mm, 100 mm 250 .798 mm, 100 mm 250 mmFixation Material, MR mm Carbon Fiber Bridging Rods mm, short mm, long mm, short mm, long Fixation * Spring-Loaded *Adjustable * Open *Universal Joint for Two * Universal ClampProtective * For mm Fixation Pins, (10/pkg.) * For mm Fixation Pins, (10/pkg.) Sterile-Packaged Large External Fixator External Fixator Ankle Frame Kit, External Fixator Trauma Kit, External Fixator Pelvic Frame Kit, *This item has not been tested for use in the MR External Fixator modular knee bridge Technique Power Drive ComPact Air Drive II SetAccessories for Graphic Label Sheet Pack, for Large External Fixator Label Sheet Pack, for Schanz Screws Brackets, (3 sizes) Screws, (10/pkg.)

10 Sheet, for Large External Fixator clampsAlso Available continuedSynthesManufactured or distributedin the United States by:Synthes, Wrights Lane EastWest Chester, PA 19380 Telephone: (610) 719-5000To order: (800) manufacturer in Canada:Synthes (Canada) Meadowpine BoulevardMississauga, Ontario L5N 6P9 Telephone: (905) 567-0440To order: (800) 668-1119 Fax: (905) 567-3185 DePuy Synthes Trauma, a division of DOI 2014. All rights 3/14 CAUTION: USA Law restricts these devices to sale by or on the order of a physician.