BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FF 360FAST-FIX 360 REVERSED CURVE NDL DELIV

    MDR report key: 4913413 · Received July 14, 2015

    Report

    Report Number
    1219602-2015-00348
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    November 19, 2014
    Report Date
    July 14, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER; INTERNATIONAL PHONE NUMBER (B)(6). EVALUATION OF RETURNED DEVICE REVEALED THAT THE ACTUATOR ROD WAS IN THE T2 PREDEPLOYMENT POSITION AND THE IMPLANT WAS VISUALLY EVALUATED AT 10 X WITH AN EYE LOUPE. NO ISSUES WERE IDENTIFIED WITH THE IMPLANT THAT CAN BE IDENTIFIED TO HAVE CONTRIBUTED THE EVENT AND THE COMPLAINT MODE CANNOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A MENISCUS REPAIR USING A FAST-FIX 360 REVERSE CURVED, A SIMULTANEOUS DEPLOYMENT OCCURRED WHEN THE DEPLOYMENT KNOB WAS DEPRESSED TO DEPLOY T1, T2. THE PROCEDURE WAS COMPLETED WITH ANOTHER FAST-FIX 360.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456026 FF 360FAST-FIX 360 REVERSED CURVE NDL DELIV SUTURE, NONABSORBABLE, SYNTHETIC, PE GAT SMITH & NEPHEW, INC. 50502413

    Patients

    Seq Age Sex Outcome Treatment
    1