BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL FOR 12MM SCREWS, DIAM1.0X54MM, WL 13

    MDR report key: 1930394 · Received November 18, 2010

    Report

    Report Number
    8010177-2010-00433
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HBE
    PMA / PMN Number
    K070876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    SURGEON WAS USING DRILL BIT TO DRILL TACK SUTURES INTO SKULL AND THE TIP OF THE DRILL BIT CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL FOR 12MM SCREWS, DIAM1.0X54MM, WL 13 INSTRUMENT HBE STRYKER OSTEOSYNTHESIS FREIBURG NA AA08/EA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK