BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 6 RECIP

    MDR report key: 1960738 · Received December 16, 2010

    Report

    Report Number
    1811755-2010-02043
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE EVENT WAS CONFIRMED TO BE AN INTERMITTENT EBOX. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW IS RUNNING HOT. THIS WAS DISCOVERED DURING A CASE. THERE WAS NO PATIENT INJURY AND NO ADVERSE CONSEQUENCES. THERE WAS NO DELAY, A BACKUP WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYS 6 RECIP INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK