BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FF 360

    MDR report key: 3200129 · Received July 1, 2013

    Report

    Report Number
    1219602-2013-00145
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - ONE DEVICE WAS RETURNED FOR EVALUATION. NO TS OR SUTURE RETURNED. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE ACTUATED AND CYCLED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. A COMPLAINT HISTORY REVIEW IDENTIFIED TWO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. DUE TO THIS FACT WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. (B)(4).

    Description of Event or Problem · 1

    DURING A KNEE ARTHROSCOPY SURGEON WAS UTILIZING A FAST-FIX 360. T1 WAS DEPLOYED SUCCESSFULLY, HOWEVER, T2 FAILED TO DEPLOY AFTER ACTUATING THE DEVICE. T2 WAS FOUND TO BE UNDERNEATH THE MENISCUS RATHER THAN CLOSING THE TEAR. CONSEQUENTLY, T1 REMAINED IN THE PATIENT UNSUPPORTED AND T2 WAS REMOVED FROM THE JOINT. A BACK UP DEVICE WAS ON HAND TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299327 FF 360 FAST-FIX 360 CURVED NDL DELIVERY SYS GAT SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 50444627

    Patients

    Seq Age Sex Outcome Treatment
    1