BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 2050024 · Received March 14, 2011

    Report

    Report Number
    1811755-2011-00789
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE LEAKING COULD NOT BE DUPLICATED. SUBSTANCE SAMPLES WERE TAKEN FOR FURTHER ANALYSIS. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW WAS LEAKING AROUND THE BLADE MOUNT DURING A TOTAL HIP REPLACEMENT. PROCEDURE WAS COMPLETED WITH ANOTHER SAW. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK