BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 3842522 · Received June 2, 2014

    Report

    Report Number
    0009610622-2014-00253
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. PRODUCT DETAILS : UNKNOWN GAMMA NAIL.. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AFFECTED ITEMS WERE NOT RETURNED FOR EVALUATION. THE DHR COULD NOT BE REVIEWED AS THE LOT CODES OF THE BROKEN IMPLANTS ARE UNKNOWN. ON RECEIVED X-RAYS NO DEFICIENCIES OF THE DEVISES WERE VISIBLE THE RISK ANALYSIS HAD CONSIDERED IMPLANT BREAKAGE; THE ESTIMATED THRESHOLDS (S AND O) WERE NOT EXCEEDED. WITH AVAILABLE INFORMATION THE CAUSE OF THE EVENT CANNOT BE DETERMINED. WITH RESPECT TO THE LONG IMPLANTATION TIME IT CAN BE CONCLUDED THAT THE BREAKAGE IS RATHER BASED ON THE PATIENT¿S CONDITION AND NOT CAUSED BY A DEFICIENCY OF THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GAMMA NAIL IMPLANTED. THE GAMMA NAIL WAS FOUND TO BE FRACTURED AT THE LAG SCREW HOLE. ONE DISTAL INTERLOCKING SCREW BROKE INTO THREE PIECES. DURING REVISION THE ALIGNMENT OF THE FEMUR WAS RESTORED AND A BLADE PLATE WAS INSERTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GAMMA NAIL IMPLANTED. THE GAMMA NAIL WAS FOUND TO BE FRACTURED AT THE LAG SCREW HOLE. ONE DISTAL INTERLOCKING SCREW BROKE INTO THREE PIECES. DURING REVISION THE ALIGNMENT OF THE FEMUR WAS RESTORED AND A BLADE PLATE WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321731 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER TRAUMA KIEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention