BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2853971 · Received October 24, 2012

    Report

    Report Number
    1811755-2012-03872
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY, THE DRILL WAS EMITTING SMOKE FROM THE BASE, AS WELL AS OVERHEATING. DURING THE DEVICE EVALUATION, CORROSION WAS FOUND IN THE MOTOR ASSEMBLY, AND THE DRIVESHAFT AND ROTOR BEARINGS WERE FOUND NOT TURNING SMOOTHLY, WHICH CAN BE PROBABLE CAUSES OF THE DEVICE OVERHEATING AND SMOKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK