BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING RECONSTRUCTION PLATE AXSOS 14 HOLE / L222MM 5.0MM LOCKING SET

    MDR report key: 3071000 · Received April 22, 2013

    Report

    Report Number
    0008031020-2013-00106
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K060798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE IS BROKEN IN THE 7TH HOLE. DUE TO THE BREAKAGE, THE RETURNED DEVICE IS NOT FUNCTIONAL ANYMORE. BECAUSE OF THE BREAKAGE A MEASUREMENT OF THE DIMENSIONS WAS NOT POSSIBLE. HOWEVER, DURING THE MANUFACTURING A 100% INSPECTION (IN-PROCESS-CONTROL) OF THE RELEVANT FUNCTIONAL DIMENSIONS OF EACH PLATE TOOK PLACE. THE REVIEW SHOWED THAT ALL DIMENSIONS MET THE SPECIFICATIONS. THERE ARE SOME CORROSION MARK ON THE BREAKAGE SITE. THE AFFECTED DEVICE WAS SENT TO (B)(4) FOR FURTHER INVESTIGATION. SUMMARY, THE ITEM EXAMINED WAS A BROKEN OSTEOSYNTHESIS PLATE. THE RESULTS CAN BE BRIEFLY SUMMARIZED AS FOLLOWS: UNDER MACROSCOPIC EXAMINATION, THE FRACTURE SURFACE DISPLAYED PATTERNS SIMILAR TO BEACH LINES. UNDER MICROSCOPIC EXAMINATION, STRIATIONS AND SECONDARY CRACKS WERE DISCERNIBLE ON THE FRACTURE SURFACE. EVIDENCE OF SECONDARY CRACKS, INTRUSIONS AND EXTRUSIONS COULD BE FOUND ON THE OUTER SIDE OF THE PLATE. THE MATERIAL CORRESPONDS TO A 1.4441 GRADE STEEL. BASED ON THE RESULTS OF THE EXAMINATION, IT CAN BE STATED THAT THE PLATE FAILED DUE TO A FATIGUE FRACTURE (FATIGUE FAILURE). INTERPRETATION OF THE RESULTS, THE EXAMINATION SHOWED THAT THE OSTEOSYNTHESIS PLATE FAILED DUE TO FATIGUE FRACTURE (FATIGUE FAILURE). THE FRACTURE ORIGINATION POINT WAS TRACED TO THE AREA AROUND THE SCREW HOLE CHAMFER ON THE OUTER SIDE OF THE PLATE. THE CRACK PROPAGATION POINTS TO ALTERNATING BENDING STRESS. THE AREA OF THE FATIGUE FRACTURE OCCUPIED OVER 90% OF THE ENTIRE FRACTURE SURFACE. IT CAN THEREFORE BE ASSUMED THAT THE LOAD AMPLITUDE WAS RELATIVELY LOW. THE CORROSION PRODUCT DEPOSITS AND THE RAINBOW-LIKE DISCOLORATION INDICATE THAT CRACK INITIATION AND/OR CRACK GROWTH WAS ENCOURAGED BY CORROSION. THE GAP BETWEEN THE SCREW AND SCREW HOLE IS A LOCATION IN WHICH AGGRESSIVE CORROSION CONDITIONS CAN DEVELOP. THE FRACTURE ORIGINATION POINT WAS FOUND TO BE PRECISELY IN THIS GAP. CORROSION-FACILITATED CRACK GROWTH COULD BE DEMONSTRATED BY MEANS OF A SPECIFIC, METALLOGRAPHIC INVESTIGATION; THIS IS, HOWEVER, A DESTRUCTIVE METHOD. X-RAYS AND AVAILABLE INFORMATION WERE PROVIDED TO OUR CLINICAL EXPERT. HE STATED: THE FRACTURE HAS BEEN FIXED WITH A RECONSTRUCTION PLATE. THIS TYPE OF PLATE IS DEFINITELY NOT INTENDED FOR FIXATION OF TRANSVERSE FEMUR SHAFT FRACTURES. IT IS MADE FROM ANNEALED STAINLESS STEEL WHICH IS MUCH TOO WEAK FOR THIS INDICATION. BENDING OF THE PLATE USED FOR THIS INDICATION IS UNAVOIDABLE. THIS SHOULD BE PART OF THE BASIC EDUCATION OF A TRAUMA SURGEON. SUCH A FRACTURE WOULD HAVE BEEN A GOOD INDICATION FOR AN INTRAMEDULLARY NAIL (E.G. T2 FEMUR) OR AN AXSOS DISTAL FEMUR PLATE (I.E. IN THE CASE THAT THE BROKEN SCREW WOULD NOT BE REMOVABLE). IN CONCLUSION, THIS IS CLEAR SURGICAL FAILURE CAUSED BY A WRONG INDICATION OF THE PLATE TYPE. RECONSTRUCTION PLATES ARE ONLY USEFUL IN SPECIFIC INDICATIONS (E.G. PELVIC FRACTURES). A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    BROKEN PLATE.

    Description of Event or Problem · 1

    BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172951 LOCKING RECONSTRUCTION PLATE AXSOS 14 HOLE / L222MM 5.0MM LOCKING SET IMPLANT HRS STRYKER OSTEOSYNTHESIS-SELZACH X27100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention