Instructions for Use Reprocessed Non Sterile External Fixation Devices

Transcription

1 Reprcessed by Instructins fr Use Reprcessed Nn Sterile External Fixatin Devices Reprcessed Device fr Single Use Cautin: Federal (U.S.A.) law restricts this device t sale by r n the rder f a physician. Explanatin f Symbls Date f Reprcessing D Nt Reuse Cnsult Instructins Fr Use Nn-sterile REF LOT Catalg Number Batch Number Stryker Sustainability Slutins, Inc. 2010, W. Drake Drive Tempe, AZ sustainability.stryker.cm

2 External Fixatin Devices Descriptin External fixatin devices are specially designed frames, clamps, rds, rd-t-rd cuplings, pins, psts, fasteners, wire fixatins, fixatin blts, washers, nuts, hinges, sckets, cnnecting bars and screws used fr the management f bne fractures and recnstructive, as well as crrective, rthpedic surgery. Materials used include metal allys, plastic and cmpsites. These materials are chsen t address a wide range f fractures and applicatins as well as t allw fr the apprpriate amunt f rigidity and stability. An external fixatin system is a mdular system. The system is designed t prvide ptins in frame cnstructin, simplicity in frame cmpnents, and ease f transitin frm ne frame size t anther. NOTE: Stryker Sustainability Slutins nly reprcesses the external parts f the systems. The pins that are inserted thrugh the skin t the bne are single use implants that are nt reprcessed. Indicatins fr Use Synthes, Smith and Nephew, EBI/Bimet, Orthfix, DePuy, SBI: Reprcessed external fixatin devices are indicated fr use in patients requiring external skeletal fixatin and treatment f fractures, stetmy, arthrdesis, crrectin f defrmities, fracture revisin, bne recnstructin prcedures, limb lengthening, crrectin f bny r sft tissue defrmities and segmental bny r sft tissue defects. Zimmer TransFx external fixatin devices are indicated fr fractures f the lng bnes and pelvis, jint fusin, limb lengthening, stetmies, and periarticular fractures. Cntraindicatins fr Use Reprcessed external fixatin devices are cntraindicated fr the fllwing: When there is an active infectin. Fr disabled r nn-cmpliant individuals wh cannt perfrm the necessary pstperative care. Fractures that will heal satisfactrily with cnservative treatment. Reprcessed external fixatin devices are relatively cntraindicated fr use in patients with the fllwing: Knwn sensitivity and/r allergies t the materials in the external fixatin device mdel t be used. Histry f frequent infectins. Neurmuscular deficiencies. Significant deficiency in bne quantity and quality. Inadequate r impaired bld flw in the bdy site(s) t be treated. Malignant bne grwth in fracture area. Obesity that culd lead t the failure f the device. Warnings These external fixatin devices are nly intended fr use by individuals with adequate training and familiarity with techniques assciated with the rthpedic surgical prcedure emplyed. Fr further infrmatin abut techniques, cmplicatins and hazards, cnsult the medical literature. The use f these devices requires a thrugh understanding f the techniques and principles f rthpedic surgery prcedures. Prjectiles frm wire r pin cutting culd cause injury t patient r medical persnnel during surgery. Preperative frame assembly and adequate supply f cmpnents is recmmended. Intraperative fracture r breakage f instruments can ccur (e.g. due t excessive frce, extensive use). Inspect all external fixatin devices and cmpnents prir t surgery. Replace when necessary. As a part f the preperative preparatin and surgery planning phase it is advisable t anticipate varus, valgus, prcurvatum and recurvatum distractin by selectin f an apprpriate prphylactic ring tilt and strategically psitining f wires with stppers, fulcrums, half pins, and hinges. Avid damage t nerves, muscles, tendns, and vessels by careful placement f wires and pins. Avid heat necrsis f surrunding tissue and bne by drilling wires slwly thrugh the bne. Hld wire tips when clipping and wear eye prtectin. Handle the sharp tips f wires with cautin. Maintain meticulus daily pin and wire site care management t prevent infectin. Use peridic pstperative fllw-ups and radigraphs t mnitr the distractin phase.

3 Precautins Ensure cmpatibility f all devices used in a single prcedure. Select the apprpriate mdel and material f external fixatin device(s) fr the patient s treatment needs as well as the clinical utcme desired. D nt apply excessive frce t external fixatin devices. Reprcessed external fixatin devices are nt cmpatible with magnetic resnance imaging (MRI) techniques, unless specified therwise in the Prduct Labeling r respective Prduct Literature. Use utmst care in handling and string f devices t prevent cutting, bending r scratching f the device. Securely fasten all wires and miscellaneus parts. Refer t prduct literature fr the tensining f wires. Use a wire diameter with sufficient strength fr maintaining the apprpriate axial stiffness f the device. Allw fr patient limb swelling when chsing sizes f rings, half rings and frames. Rutinely check the security f wires and pins, the tensin f wires, and the verall integrity f frame cmpnents. Preperative Care Preparatin shuld include prvisin f a sufficient surplus supply f sterile cmpnents. Ensure prper tightening f screws. Pstperative Care Advise the patient f the imprtance f cmplying with: - The surgen s warnings and recmmendatins regarding the use and daily care f the external fixatin devices, including tpical cleaning using 2% hydrgen perxide slutin in sterile water and rutine shwering with antibacterial sap. - Daily cleansing f pin-skin interface, - The limitatins in weight bearing as cmpared t that f a nrmal, healthy bne, - The limitatins f activity levels and - The medical fllw-up required. Advise the patient t reprt unanticipated reactins r prblems withut delay. Visualize and reevaluate the bne healing prgress and arrange fr adjustments accrdingly. When applicable, tuch dwn weight bearing may be allwed after surgery and gradually increased as the callus thickens and matures. Weekly t biweekly fllw-up and radigraphs are recmmended during the distractin phase. Adverse Reactins Injury f nerves r vessel. Edema. Premature bne cnslidatin. Ostemyelitis. Damage t sft tissue (e. g. tendns r ligaments). Abnrmal grwth plate develpment (in patients wh are skeletally immature). Necrsis due t bne screw r wire insertin. Pin lsening. Excessive perative bleeding. Intractable pain. Vascular disrders (thrmbphlebitis, pulmnary emblus, wund hematmas, avascular necrsis). Cmpartment syndrme. Fracture f regenerated bne. Bne defrmity. Chrnic drainage f bne screw r wire sites after device remval. Inadequate fracture reductin because f failure t pin the bne segments crrectly. Failure f bne t regenerate satisfactrily. Ankle stiffness (if multiple transfixin pins are used in tibial fractures). Deep r superficial infectin. Thrmbsis, late ersin r arterivenus fistulas. Lss f bne mass. Septic Arthritis. Anther peratin t replace r change the device. Freign bdy reactin r metal sensitivity. Neurlgical cmplicatins, including pssibly palsy. Pressure prblems caused by external cmpnents. Limb length discrepancy. Intrinsic risks assciated with anesthesia. Tissue necrsis. Pin breakage r mvement at the fracture site caused by use f t few pins r pins that are t small. Nnunin r pseudarthrsis. Bne damage. Equinus defrmity. Jint cntracture, subluxatin, dislcatin r lss f range f mtin. Excessive mtin at the fracture site caused by failure t tighten the cmpnent parts f the device. Bne separatin induced by rapid drilling f the bny crtex.

4 Directins fr Use 1. Inspect the device fr verall cnditin and physical integrity. D nt use the device if any damage is nted. Return the device t Stryker Sustainability Slutins if it is nt in acceptable cnditin fr surgery. 2. Sterilizatin Unless therwise nted, Stryker Sustainability Slutins external fixatin cmpnents are prvided NON-STERILE. All NON-STERILE cmpnents must be prperly sterilized fllwing the recmmended sterilizatin prcedures: Methd Cycle Temperature Time Steam Pre-Vacuum 132 C 270 F 18 minutes Sterilizer manufacturer recmmendatins shuld always be fllwed. Sterility cannt be assured if the sterilizatin tray is verladed. When sterilizing multiple instrument sets in ne sterilizatin cycle, ensure that the manufacturer s maximum lad is nt exceeded. Nte: Steam sterilizatin is nt recmmended fr any plastic cmpnent Cautin is recmmended during sterilizatin and strage s as t prevent cntact with metal r ther hard bjects that culd damage the finish r prevent prper assembly. 3. Befre beginning the prcedure, verify cmpatibility f all devices and accessries t be emplyed in the planned surgical prcedure. NOTE: Additinal equipment r tling may be required t cnstruct r de-cnstruct the system. 4. Use the pins that are cmpatible with the external fixatin system being used. Stryker Sustainability Slutins des nt prvide pins. 5. Place the cmpnents t be used in a sterile wrk area using aseptic technique. 6. Cnsider preliminary frame assembly t shrten the prcedure. 7. Verify if the prduct supply is sufficient t cmplete the intended prcedure. 8. Fllw a suitable rthpedic surgery prtcl. 9. Securely fasten all cmpnents. 10. Device is intended fr single use during a single patient rthpedic prcedure and can be returned t Stryker Sustainability Slutins fr reprcessing. Strage and Handling Stre in a dry envirnment. The devices shuld never be stred in a wet r mist cnditin.

5 Warranty Reprcessed Prducts Stryker warrants all reprcessed prducts, subject t the exceptins prvided herein, t be free frm defects in reprcessing and t substantially cnfrm t the prduct specificatins cntained in the dcumentatin prvided by Stryker with the prducts fr ne use in accrdance with the instructins fr use f such prduct. STRYKER SHALL NOT BE LIABLE FOR ANY DAMAGES TO THE EXTENT CAUSED BY ANY DEFECT IN MATERIAL, WORKMANSHIP OR DESIGN BY THE ORIGINAL MANUFACTURER OF THE PRODUCT OR ANY ACT OR OMISSION OF THE ORIGINAL MANUFACTURER OF THE PRODUCT. Prducts fr which Stryker is the Original Manufacturer Stryker warrants all prducts fr which it is the riginal manufacturer, subject t the exceptins prvided herein, t be free frm defects in design, materials and wrkmanship and t substantially cnfrm t the prduct specificatins cntained in the dcumentatin prvided by Stryker with the prducts fr a perid f ne year frm the date f purchase. General Warranty Terms Applicable t All Prducts TO THE FULLEST EXTENT PERMITTED BY LAW, THE EXPRESS WARRANTY SET FORTH HEREIN IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTY BY STRYKER, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL STRYKER S LIABILITY ARISING IN CONNECTION WITH THE SALE OF THE PRODUCT (WHETHER UNDER THE THEORIES OF BREACH OF CONTRACT, TORT, MISREPRESENTATION, FRAUD, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR ANY OTHER THEORY OF LAW) EXCEED THE PURCHASE PRICE, CURRENT MARKET VALUE OR RESIDUAL VALUE OF THE PRODUCTS, WHICHEVER IS LESS. STRYKER SHALL NOT BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR UNDER ANY OTHER LEGAL THEORY. This warranty shall apply nly t the riginal end-user purchaser f prducts directly frm Stryker r a Stryker authrized distributr. This warranty may nt be transferred r assigned withut the express written cnsent f Stryker. This warranty des nt apply t: (1) prducts that have been misused, neglected, mdified, altered, adjusted, tampered with, imprperly installed r refurbished; (2) prducts that have been repaired by any persn ther than Stryker persnnel withut the prir written cnsent f Stryker; (3) prducts that have been subjected t unusual stress r have nt been maintained in accrdance with the instructins in the user manual r as demnstrated by a Stryker representative; (4) prducts n which any riginal serial numbers r ther identificatin marks have been remved r destryed; r (5) prducts that have been repaired with any unauthrized r nn-stryker cmpnents. If a valid warranty claim is received within thirty (30) days f the expiratin f the applicable warranty perid, Stryker will, in its sle discretin: (1) replace the prduct at n charge with a prduct that is at least functinally equivalent t the riginal prduct r (2) refund the purchase price f the prduct. If a refund is prvided by Stryker, the prduct fr which the refund is prvided must be returned t Stryker and will becme Stryker s prperty. In any event, Stryker s liability fr breach f warranty shall be limited t the replacement value f the defective r nn-cnfrming part r cmpnent. If Stryker determines in its reasnable discretin that the claimed defect r nn-cnfrmance in the prduct is excluded frm warranty cverage as described hereunder, it will ntify the custmer f such determinatin and will prvide an estimate f the cst f repair f the prduct. In such an event, any repair wuld be perfrmed at Stryker s standard rates. Prducts and prduct cmpnents repaired r replaced under this warranty cntinue t be warranted as described herein during the initial applicable warranty perid r, if the initial warranty perid has expired by the time the prduct is repaired r replaced, fr thirty (30) days after delivery f the repaired r replaced prduct. When a prduct r cmpnent is replaced, the item prvided in replacement will be the custmer s prperty and the replaced item will be Stryker s prperty. If a refund is prvided by Stryker, the prduct fr which the refund is prvided must be returned t Stryker and will becme Stryker s prperty.

6 The OEM infrmatin listed n the label is prvided as device ID prir t reprcessing and may cntain the trademarks f unrelated third parties that d nt spnsr this device. Zimmer TransFx is a trademark f Zimmer Hldings, Inc. NEX Rev J RM702014