BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS4 ROTARY HANDPIECE

    MDR report key: 1851029 · Received September 27, 2010

    Report

    Report Number
    1811755-2010-01254
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RETURNED AND THE MFR COULD NOT DUPLICATE THE COMPLAINT. THE ASIC MOTOR CONTROL WIRING APPEARED TO HAVE BEEN TAMPERED BY A 3RD PARTY. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING FOR A PROCEDURE THE HANDPIECE BEGAN OT HEAT UP, FOLLOWED BY A SMELL OF BURNED WIRES AND THEN SMOKE APPEARED. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYS4 ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK