BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2213845 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02806
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE EVENT AS REPORTED BY THE CUSTOMER WAS DUPLICATED. THE HANDPIECE HAD A CORRODED ROTOR AND DRIVESHAFT. IT IS LIKELY THAT THE CORROSION CAUSED ROTOR RUB, WHICH RESULTED IN THE DEVICE OVERHEATING. THE DHR WAS REVIEWED AND THIS DEVICE MET SPECS WHEN IT WAS RELEASED. THERE WERE NO DESIGN CHANGES, NONCONFORMANCE DOCUMENTS, OR REWORKS ASSOCIATED WITH THE PRODUCT IN THIS COMPLAINT OR WITHIN TWO WEEKS OF ITS MANUFACTURE THAT COULD HAVE CONTRIBUTED TO THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL WAS OVERHEATING AT THE HANDLE WHILE BEING PREPARED FOR A PROCEDURE. ANOTHER DRILL USED TO COMPLETE THE PROCEDURE COMPLETELY. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO BURN OR INJURY TO THE PT OR USER IN THIS EVENT.

    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