BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE, T10, AO

    MDR report key: 1833328 · Received September 13, 2010

    Report

    Report Number
    8010177-2010-00310
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 14, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THE ROOT CAUSE FOR THE EVENT CAN THEREFORE NOT BE DETERMINED. POSSIBLE ROOT CAUSES MAY HAVE BEEN A PRE-DAMAGED SCREWDRIVER BLADE DUE TO: INADEQUATE SCREWDRIVER/SCREW HEAD CONNECTION, TOO HIGH BENDING FORCES, TOO HIGH TORQUE. BASED ON STATISTICAL EVAL NO INDICATION WAS FOUND FOR ANY DEVICE RELATED ISSUE. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. IF THE PRODUCT IS LOCATED AND RETURNED LATER, THE COMPLAINT WILL BE RE-OPENED AND AN APPROPRIATE INVESTIGATION PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE TIP OF THE SCREWDRIVER STOPPED ENGAGING IN THE SCREWS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BLADE, T10, AO INSTRUMENT HXX STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR