BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    34KHZ SM LONG ANGLED W/O TIP

    MDR report key: 3946103 · Received July 21, 2014

    Report

    Report Number
    0001811755-2014-02580
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMMENT OF THE ANGLE JOINT BEING MISSING WAS CONFIRMED DURING SERVICE EVALUATION. DURING SERVICE EVALUATION IT WAS OBSERVED THE ANGLE NUT WAS MISSING DUE TO DAMAGE. A DAMAGED ANGLE NUT CAN BE CAUSED BY OVER TORQUING OF THE ANGLE NUT WHILE ATTACHING A TIP TO THE HANDPIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MALE THREADED TIP WAS MISSING WHEN THE 34KHZ SM LONG ANGLED W/O TIP WAS OPENED PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK UP DEVICE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MALE THREADED TIP WAS MISSING WHEN THE 34KHZ SM LONG ANGLED W/O TIP WAS OPENED PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK UP DEVICE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424666 34KHZ SM LONG ANGLED W/O TIP INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1