BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE SAG SAW

    MDR report key: 1942270 · Received December 22, 2010

    Report

    Report Number
    1811755-2010-02113
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE INVESTIGATION CONFIRMED THAT THERE WAS AN EXCESSIVE NOISE COMING FROM THE MOTOR. DURING THE REPAIR, IT WAS ALSO REPORTED THAT THE CONTACT PINS IN THE MOTOR CARTRIDGE WERE BURNT AND THAT THE HANDPIECE EXCEEDED MAXIMUM TEMPERATURE RISE DURING TESTING. THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE BALL BEARING AND MID SPEED MOTOR IN ADDITION TO OTHER COMPONENTS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING ROUTINE MAINTENANCE TESTING BY THE MANUFACTURER. THIS DID NOT OCCUR DURING ANY SURGICAL OR MEDICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention