BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SCREW ASNIS III Ø6.5X80MM TL20MM

    MDR report key: 3160799 · Received June 11, 2013

    Report

    Report Number
    0008031020-2013-00182
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K024060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. THE PATIENT WAS REPORTED TO HAVE DISEASE WHICH COULD HAVE EXPLAINED THE POOR FIXATION AND THE BACK OUT. PLEASE NOTE THAT THE CURRENT IFU AND OP TECH READ: CONTRAINDICATION: BONE STOCK COMPROMISED BY DISEASE, INFECTION OR PRIOR IMPLANTATION THAT CANNOT PROVIDE ADEQUATE SUPPORT AND/OR FIXATION OF THE DEVICES. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    CONVERTED 3 CANNULATED SCREWS INTO A TOTAL HIP. PER SALES REP VIA E-MAIL RECEIVED ON (B)(4) 2013: "SCREWS WERE PROTRUDING POSTERIORLY OUT OF THE FEMORAL HEAD. PATENT ALSO HAD A VERY ARTHRITIC HIP SO THE SURGEON DECIDED TO REPLACE WITH A TOTAL HIP ARTHROPLASTY."

    Description of Event or Problem · 1

    CONVERTED 3 CANNULATED SCREWS INTO A TOTAL HIP. PER SALES REP VIA E-MAIL RECEIVED ON (B)(6) 2013: "SCREWS WERE PROTRUDING POSTERIORLY OUT OF THE FEMORAL HEAD. PATENT ALSO HAD A VERY ARTHRITIC HIP SO THE SURGEON DECIDED TO REPLACE WITH A TOTAL HIP ARTHROPLASTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262848 CANNULATED SCREW ASNIS III Ø6.5X80MM TL20MM IMPLANT HWC STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention