BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM

    MDR report key: 2093182 · Received April 14, 2011

    Report

    Report Number
    8010177-2011-00116
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED FOR ANALYSIS. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DOCTOR WAS PUTTING THE SCREW IN FOR A BUNION AND THE TIP OF THE SCREWDRIVER BROKE OFF. THE PIECE WAS RETRIEVED."

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR