BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1813038 · Received August 13, 2010

    Report

    Report Number
    1811755-2010-00945
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVAL, BUT THE REPORTED CONDITION OF THE DEVICE OVERHEATING COULD NOT BE CONFIRMED. DURING TESTING, EXCESSIVE NOISE AND VIBRATION WERE COMING FROM THE MOTOR ASSEMBLY. THE ROTOR WAS BALANCED AND THE BEARINGS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING AT THE MID-POINT TO END OF THE PROCEDURE. THERE WAS NO REPORTED PT 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 BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK