BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 3051631 · Received April 10, 2013

    Report

    Report Number
    0001811755-2013-00757
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION A CORRODED ROTOR ASSEMBLY WAS FOUND, WHICH WAS IDENTIFIED AS A PROBABLE CAUSE OF THE DEVICE STICKING IN RUN MODE AS WELL WAS THE BUR BREAKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DRILL WAS STUCK IN THE "RUN" SETTING AND CONTAINED A BROKEN BUR. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152135 UNIVERSAL HIGH TORQUE DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BUR