BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FF 360

    MDR report key: 3200254 · Received July 1, 2013

    Report

    Report Number
    1219602-2013-00146
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: EVALUATION RESULTS: FIVE DEVICES WERE RETURNED FOR EVALUATION ONE OF WHICH IS MISSING ITS DEPTH LIMITER. ALL DEVICE ACTUATORS ARE AT THE T2 POST DEPLOYMENT POSITION. THE LOCATION OF THE ACTUATOR FOR ALL DEVICES IS NOT CONSISTENT WITH THE REPORTED FAILURE MODE OF T2 PREDEPLOYMENT. NO SUTURE OR T ASSEMBLIES WERE RETURNED FOR EVALUATION. ALL DEVICES WERE FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING AND ALL WERE FOUND TO FUNCTION AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS ASSOCIATED WITH THE MANUFACTURED LOTS IN QUESTION CONFIRMED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN FILED AND THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE. DUE TO THESE OBSERVATIONS NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. COMP-0048620 07/01/2013 (MP)

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR THE SURGEON WAS UTILIZING A TOTAL OF FIVE FAST-FIX 360 CURVED DEVICES (LOT NUMBERS: 50446356, 50447896, 50448013, AND 50448715 X 2). REPORTEDLY, T1 WAS DEPLOYED CORRECTLY, HOWEVER UPON REMOVING THE INSERTER NEEDLE THE T2 IMPLANT GOT LOOSE FROM THE INSERTER AND PRE-DEPLOYED WITHOUT ACTIVATING THE ACTUATOR. IMPLANT WAS CUT FROM THE MENISCUS. THE SURGEON WAS ABLE TO SUTURE THE MENISCUS BY USING ANOTHER FAST-FIX 360 DEVICE. THE RESULT OF THE REPAIR WAS SATISFIED BUT IT TOOK EXTRA TIME. THE REPORTER COULD NOT CONFIRM THAT T1 WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN WHICH LOT(S) EXPERIENCED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299297 FF 360 FAST-FIX 360 CURVED NDL DELIVERY SYS GAT SMITH & NEPHEW MANSFIELD MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1