BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 4910520 · Received July 13, 2015

    Report

    Report Number
    1219602-2015-00315
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    January 15, 2015
    Report Date
    July 13, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE SHOWS T1 IS FREE FROM THE NEEDLE. THE ACTUATOR IS IN THE PRE-T2 DEPLOYMENT POSITION INDICATING A DEPLOYMENT OF T1. THE TRIGGER WAS ADVANCED AND T2 DEPLOYED AS INTENDED. THE DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING AND WAS FOUND TO FUNCTION AS INTENDED. DEVICE WAS NOT RETURNED IN THE CONDITION OF THE REPORTED COMPLAINT. A ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCUS REPAIR PROCEDURE, IT WAS REPORTED THAT AFTER DEPLOYING T2, THE SUTURES GOT STUCK; IT WAS IMPOSSIBLE TO SLIDE IT AND REPAIR THE MENISCUS. A BACK UP DEVICE WAS UTILIZED AND THE PRODUCT WAS ABLE TO BE REMOVED FROM THE PATIENT. A TEN MINUTE DELAY WAS REPORTED. THE DEVICE WAS RECEIVED AND EVALUATED. T2 WAS FOUND NOT TO BE DEPLOYED AND THE ACTUATOR IN PRE-T2 DEPLOYMENT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452490 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50527941

    Patients

    Seq Age Sex Outcome Treatment
    1