BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3220940 · Received July 11, 2013

    Report

    Report Number
    0001811755-2013-01626
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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

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

    Additional Manufacturer Narrative · 1

    THE REPORTED BLADE WHIP WAS CONFIRMED UPON FUNCTIONAL EVALUATION BY A MANUFACTURER SERVICE TECHNICIAN. A LOOSE DRIVE LINK ON THE BLADE MOUNT BASE WAS IDENTIFIED, AND IS THE PROBABLE CAUSE OF THE REPORTED BLADE WHIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY BLADE WHIP WAS OBSERVED, CAUSING THE BLADE TO POP OUT 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, CAUSING THE BLADE TO POP OUT 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
    319582 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1