BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 3780992 · Received April 30, 2014

    Report

    Report Number
    0001811755-2014-01566
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION, THE THREADS ON THE ANGLE NUT WERE CONFIRMED TO BE BROKEN OFF. ATTEMPTS WERE MADE WITH NEW ANGLE NUTS TO BRING THE HANDPIECE INTO PROPER ALIGNMENT, BUT THEY WERE NOT SUCCESSFUL. THE DEVICE WAS SCRAPPED AT THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP NUT OF THE UNIVERSAL HANDPIECE WAS DISCOVERED TO BE BROKEN AFTER SUCCESSFUL COMPLETION OF A PROCEDURE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259707 UNIVERSAL HANDPIECE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1