BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 3023053 · Received March 27, 2013

    Report

    Report Number
    0001811755-2013-00613
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE HANDPIECE HAD BEEN OVER-TORQUED. REPEATEDLY OVER-TORQUING THE ANGLE NUT IS A PROBABLE CAUSE OF THE ANGLE NUT THREADS BREAKING OFF. THE HANDPIECE WAS SCRAPPED AS IT WAS NOT REPAIRABLE.

    Additional Manufacturer Narrative · 1

    THE REPORTED DAMAGED EXTERNAL ANGLE NUT THREADS ON THE HANDPIECE FOUND DURING THE DEVICE EVALUATION AT THE MANUFACTURER FACILITY ARE NOT ON THE OUTSIDE OF THE DEVICE WHEN THE TIP IS ATTACHED AND THE DEVICE IS IN USE. OVER-TORQUING OF THE HANDPIECE CAN ONLY HAPPEN WHEN THE TIP IS BEING ATTACHED OR WHEN IT IS REMOVED, IF THE DEVICE IS BEING UNSCREWED IN THE WRONG DIRECTION. THIS HAPPENS AWAY FROM THE PATIENT BEFORE OR AFTER THE HANDPIECE IS USED IN A SURGICAL PROCEDURE. WITH BROKEN ANGLE NUT THREADS, THE TIP CANNOT BE CONNECTED AND THEREFORE THE DEVICE BECOMES UNUSABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VISUAL INSPECTION CONDUCTED AT THE MANUFACTURER FACILITY, THE ANGLE NUT THREADS OF THE HANDPIECE WERE FOUND TO BE BROKEN OFF ON ONE SIDE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VISUAL INSPECTION CONDUCTED AT THE MANUFACTURER FACILITY, THE ANGLE NUT THREADS OF THE HANDPIECE WERE FOUND TO BE BROKEN OFF ON ONE SIDE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126734 UNIVERSAL HANDPIECE INSTRUMENT, UILTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1