BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3121219 · Received May 20, 2013

    Report

    Report Number
    0001811755-2013-01159
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THROUGH FUNCTIONAL EVALUATION BY A MANUFACTURER SERVICE TECHNICIAN THAT THE DEVICE HAD BLADE WHIP. DURING DEVICE EVALUATION, THE SAGITTAL HEAD WAS FOUND TO BE CORRODED THROUGHOUT, WHICH IS A PROBABLE CAUSE OF THE REPORTED BLADE WHIP.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY BLADE WHIP WAS OBSERVED, CREATING AN INCISION LARGER THAN DESIRED. IT WAS ALSO OBSERVED THAT THE BLADE POPPED OUT OF THE WOOD DURING CUT TESTING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY BLADE WHIP WAS OBSERVED, CREATING AN INCISION LARGER THAN DESIRED. IT WAS ALSO OBSERVED THAT THE BLADE POPPED OUT OF THE WOOD DURING CUT TESTING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222127 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1