BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2243466 · Received July 13, 2011

    Report

    Report Number
    1811755-2011-02525
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE USER FACILITY DID NOT DOCUMENT THE DEVICE SERIAL NUMBER AT THE TIME OF THE EVENT. SINCE THE USER FACILITY CARRIES MORE THAN ONE MICRO DRILL AND THE CULPRIT MICRO DRILL WAS RETURNED INTO CIRCULATION, IT IS NOT POSSIBLE TO IDENTIFY THE CULPRIT DEVICE. THE SERIAL NUMBER FOR THE DEVICE IS UNK; AS A RESULT, IT IS NOT POSSIBLE TO DETERMINE THE DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A VOLUNTARY MEDWATCH REPORT THAT THE CORE MICRO DRILL OVERHEATED DURING A SURGICAL PROCEDURE AND CAUSED A FIRST DEGREE BURN TO THE RIGHT SIDE OF FACE OF THE PT JUST BELOW THE LIP. THE HANDPIECE WAS TAKEN OUT OF SVC AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    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