BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2950756 · Received February 8, 2013

    Report

    Report Number
    0001811755-2013-00211
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, CORROSION WAS DISCOVERED THROUGHOUT THE INTERNAL COMPONENTS OF THE DEVICE, INCLUDING THE MOTOR, DRIVESHAFT ASSEMBLY AND ROTOR. INCREASED FRICTION DUE TO CORROSION IS A PROBABLE CAUSE OF THE REPORTED OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, THE DRILL WAS OVERHEATING. 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
    54774 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1