BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM

    MDR report key: 1963848 · Received December 22, 2010

    Report

    Report Number
    8010177-2010-00473
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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 THAT DURING SCREWING IN THE SCREW, THE TIP OF THE SCREWDRIVER BROKE OFF.

    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 Y11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK