BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1589790 · Received January 18, 2010

    Report

    Report Number
    1811755-2010-00050
    Event Type
    Malfunction
    Date Received
    January 18, 2010
    Date of Event
    July 22, 2009
    Report Date
    July 22, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZA
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, A POSSIBLE CAUSE FOR THE OVERHEATING WAS PROBLEMS WITH THE SPINDLE HOUSING OR WORN BEARINGS. THE CORE DRIVESHAFT AND BEARINGS WERE EACH REPLACED ALONG WITH OTHER COMPONENTS AS PART OF PREVENTIVE MAINTENANCE. THE HANDPIECE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A WISDOM TOOTH REMOVAL PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC DZA STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK