BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 2964279 · Received February 15, 2013

    Report

    Report Number
    0001811755-2013-00290
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE THREADS OF THE ANGLE NUT WERE FOUND TO BE OVER-TORQUED. REPEATEDLY OVER-TORQUING THE ANGLE NUT CAN CAUSE IT TO BREAK AS WELL AS CAUSE THE HANDPIECE TO BE MISALIGNED, WHICH WAS IDENTIFIED AS A PROBABLE CAUSE OF THE REPORTED OVERHEATING. THE DEVICE COULD NOT BE REPAIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. : DEVICE NOT RETURNED TO MANUFACTURER AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY, THE HANDPIECE OVERHEATED AND THE PLASTIC SLEEVE MELTED. 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 EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY, THE HANDPIECE OVERHEATED AND THE PLASTIC SLEEVE MELTED. 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
    67339 UNIVERSAL HANDPIECE INSTRUMENT, UILTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1