BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 1911881 · Received November 23, 2010

    Report

    Report Number
    1811755-2010-01804
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION. THE REPORTED CONDITION OF THE DEVICE OVERHEATING COULD NOT BE CONFIRMED. BASED ON INVESTIGATION DETAILS, THE HANDPIECE PASSED ALL TESTING RELATED TO HEAT. THE LOWER ROTOR BEARING WAS FOUND LODGED IN THE MOTOR. THE BEARINGS AND MOTOR, ALONG WITH OTHER COMPONENTS, WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO OSCILLATING SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK