BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2200950 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02383
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WIDE SPREAD CORROSION DAMAGE WITHIN THE INTERNAL COMPONENTS WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE CORROSION CAUSED THE COMPONENTS TO STICK TOGETHER; THIS CAN RESULT IN FRICTION CAUSING EXCESSIVE HEAT PRODUCTION.

    Description of Event or Problem · 1

    THE CORE MICRO DRILL WAS SENT IN FOR EVALUATION BECAUSE IT WAS OVERHEATING DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK