BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3192945 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01489
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE NOSE CONE. THE ROTOR IS STUCK IN THE MOTOR, THE SPINDLE HOUSING IS WORN AND THE DRIVESHAFT BEARINGS ARE GRITTY.

    Description of Event or Problem · 1

    WHILE TESTING THE CORE IMPACTION DRILL AT THE MANUFACTURER IT WAS REPORTED THAT THE DEVICE HEATED UP. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293826 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1