BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL

    MDR report key: 1842022 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01038
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. BASED ON THE INVESTIGATION DETAILS, THE DRILL RAN INTERMITTENTLY AND HAD EXCESSIVE BEARING NOISE. THE MOTOR ASSEMBLY AND ROTOR ASSEMBLY WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING AND STARTED TO SMOKE AT THE END OF FINISHING A PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER INJURY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES. DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK