BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 2941867 · Received February 4, 2013

    Report

    Report Number
    0001811755-2013-00169
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED DURING FAILURE ANALYSIS THAT THE HANDPIECE HAD HIGH CURRENT DRAW, BLADE WHIP, AND REDUCED CUTTING PERFORMANCE DUE TO A WORN ECCENTRIC BEARING. BASED ON A REVIEW OF COMPLAINT TRENDING, A WORN ECCENTRIC BEARING CAN CAUSE ALL THESE SYMPTOMS.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE SYSTEM 6 SAGITTAL SAW WAS SENT FOR EVALUATION DUE TO HAVING BLADE WHIP WHICH CAUSED THE BLADE TO POP OUT THE INCISION DURING THE CUT TEST CONDUCTED BY A ROUTINE FIELD SERVICE MAINTENANCE VISIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 6 SAGITTAL SAW WAS SENT FOR EVALUATION DUE TO HAVING BLADE WHIP WHICH CAUSED THE BLADE TO POP OUT THE INCISION DURING THE CUT TEST CONDUCTED BY A ROUTINE FIELD SERVICE MAINTENANCE VISIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46268 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1