BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 REVERSED CURVE NDL DELIV

    MDR report key: 4926418 · Received July 20, 2015

    Report

    Report Number
    1219602-2015-00384
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    April 13, 2015
    Report Date
    July 15, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ONE FAST-FIX 360 REVERSED CURVED NEEDLE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE SHOWED THE ACTUATOR IS IN ITS POST T1 DEPLOYMENT POSITION INDICATING A DEPLOYMENT OF T1. NO TS OR SUTURE WERE RETURNED. THE DEPTH LIMITER IS DAMAGED LIKELY FROM OVER PENETRATION DURING INSERTION, WHICH MAY HAVE CAUSED T2 TO DISLODGE FROM THE NEEDLE. THE DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING AND WAS FOUND TO FUNCTION AS INTENDED. ALTHOUGH THE REPORTED FAILURE MODE CANNOT BE CONFIRMED, THE DESCRIBED FAILURE IS RELATED TO ROOT CAUSE INVESTIGATION WHICH HAS BEEN OPENED TO ADDRESS THIS FAILURE MODE. THIS INVESTIGATION IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR USING FAST-FIX 360 REVERSED CURVE NDL DELIV T2 DEPLOYED AT THE SAME TIME AS T1. THIS OCCURRED AFTER THE T1 HAD PASSED THROUGH THE MENISCUS. BOTH IMPLANTS WERE ABLE TO BE REMOVED AND NO DEBRIS REMAINED IN THE PATIENT. THERE WAS A PROCEDURAL DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THIS INCIDENT DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470389 FAST-FIX 360 REVERSED CURVE NDL DELIV SUTURE, NONABSORBABLE, SYNTHETIC, PE GAT SMITH & NEPHEW, INC. 50511322

    Patients

    Seq Age Sex Outcome Treatment
    1