BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM

    MDR report key: 2033706 · Received February 11, 2011

    Report

    Report Number
    8010177-2011-00046
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS IN HIS FAX THAT DURING THE FIRST TRY TO SCREW OUT A SCREW WITHOUT USING FORCE, THE TIP OF THE SCREWDRIVER BROKE OFF. THE SURGERY WAS FINISHED USING AN ALTERNATIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA Z11-K4P00F65XU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR