BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3232171 · Received July 17, 2013

    Report

    Report Number
    0001811755-2013-01664
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 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

    FAILURE ANALYSIS IN PROGRESS. FOLLOW UP WILL BE SUBMITTED ONCE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED BLADE WHIP WAS CONFIRMED BY A MANUFACTURER SERVICE TECHNICIAN THROUGH FUNCAITONAL EVALUATION. A LOOSE DRIVE LINK WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY BLADE WHIP WAS OBSERVED DURING CUT TESTING, CAUSING THE BLADE TO POP OUT OF THE INCISION. 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 DURING CUT TESTING, CAUSING THE BLADE TO POP OUT OF THE INCISION. 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
    331083 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1