BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 3850715 · Received June 5, 2014

    Report

    Report Number
    0001811755-2014-02048
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF THE TIP BREAKING ON THE HANDPIECE WAS CONFIRMED. A BROKEN ANGLE NUT CAN BE CAUSED BY OVER TORQUING OF THE ANGLE NUT WHILE ATTACHING A TIP TO THE HANDPIECE. THIS IS NOT A REPAIRABLE DEVICE; THEREFORE, IT WAS NOT RETURNED TO THE USER FACILITY FOLLOWING EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS ON THE TIPSIDE ON THE ANGLE NUT WERE BROKEN OFF OF THE UNIVERSAL HANDPIECE WHILE IN THE STERILE PROCESSING DEPARTMENT AT THE USER FACILITY. AFTER FOLLOW-UP, NO FURTHER INFORMATION WAS AVAILABLE REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS ON THE TIPSIDE ON THE ANGLE NUT WERE BROKEN OFF OF THE UNIVERSAL HANDPIECE WHILE IN THE STERILE PROCESSING DEPARTMENT AT THE USER FACILITY. AFTER FOLLOW-UP, NO FURTHER INFORMATION WAS AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329567 UNIVERSAL HANDPIECE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1