BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3925604 · Received July 10, 2014

    Report

    Report Number
    0001811755-2014-02450
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DISASSEMBLY WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH VISUAL INSPECTION. UPON DISASSEMBLY, IT WAS FOUND THAT THE BARREL WAS FRACTURED AT THE LEVER MOUNT, WHICH CAN LEAD TO THE REPORTED EVENT, AND CAN BE CAUSED BY A MATERIAL FATIGUE ISSUE OR IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE BLADE MOUNT LEVER OF THE DEVICE DISASSEMBLED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED 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
    404697 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1