BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYST

    MDR report key: 2914370 · Received January 14, 2013

    Report

    Report Number
    1219602-2013-00017
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    November 23, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SMITH & NEPHEW INC. MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR DEVICES WERE RETURNED FOR EVALUATION. NONE OF THE DEVICES HAD ANY SUTURE OR IMPLANTS REMAINING ON THE DELIVERY NEEDLE. THE DEVICES WERE FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING AND ALL WERE FOUND TO FUNCTION AS INTENDED. THE FAILURE MODE CANNOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    FOUR FAST-FIXES WERE USED BY THE SURGEON DURING ONE CASE. THE SURGEON PUSHED THE TRIGGER AND THE FIRST T WAS FIXATED OUT-SIDE THE CAPSULE IN THE RIGHT POSITION. HE PULLED THE TRIGGER BACK TO MAKE THE SECOND STITCH AND T2 CAME LOOSE FROM THE INSERTER AND INTO THE JOINT WITHOUT THE TRIGGER BEING PUSHED. T2 WAS RENDERED USELESS AND HAD TO BE CUT OUT FROM THE MENISCUS. T1 IS STILL IN THE JOINT SINCE IT IS PLACED OUTSIDE THE CAPSULE. THE SURGEON WAS ABLE TO SUTURE THE MENISCUS WITH ADDITIONAL FAST-FIX 360 IMPLANTS. THE RESULT OF THE MENISCUS REPAIR WAS SATISFACTORY BUT IT TOOK EXTRA TIME AND EXTRA COST TO DO THE SURGERY. THE SURGEON IS SKILLED IN THE USE OF FAST-FIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19724 FAST-FIX 360 CURVED NDL DELIVERY SYST FAST-FIX 360 CURVED NDL DELIVERY SYST GAT SMITH & NEPHEW INC. MANSFIELD MANUFACTURING SITE 50418513

    Patients

    Seq Age Sex Outcome Treatment
    1