BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, T7, DIAM. 2.7X16MM

    MDR report key: 3850181 · Received June 5, 2014

    Report

    Report Number
    0008010177-2014-00146
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K080667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL. NO EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON INSERTED 2.7 X 16MM VARIAX DISTAL RADIUS BONE SCREW INTO MOST PROXIMAL HOLE OF THE VARIAX WRIST PLATE. SCREW DIDN'T SEAT ALL THE WAY INTO THE PLATE. SURGEON WENT TO REVERSE SCREW OUT AND THE SCREW BROKE JUST BELOW HEAD OF SCREW. NO REPLACEMENT SCREW WAS USED AS SURGEON LEFT SHAFT OF SCREW INSIDE PATIENT BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329634 BONE SCREW, T7, DIAM. 2.7X16MM PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other