BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 5084725 · Received September 17, 2015

    Report

    Report Number
    1219602-2015-01012
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RECEIVED, EVALUATION HAS NOT YET BEGUN. (B)(4).

    Additional Manufacturer Narrative · 1

    THREE USED FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEMS WERE RETURNED FOR EVALUATION. DEVICES WERE RETURNED IN THE SAME PACKAGING MAKING LOT IDENTIFICATION PROHIBITIVE. VISUAL ASSESSMENT OF EACH DEVICE SHOWED NO TS OR SUTURE REMAINS ON THE NEEDLES. ONE SUTURE/T CONSTRUCT WAS RETURNED. EXAMINATION OF THE CONSTRUCT SHOWED BOTH TS ARE BENT AND T1 IS MISSING ITS DISTAL END. DIMENSIONAL INSPECTION IS PROHIBITIVE AS A RESULT OF THIS DAMAGE. THE ACTUATOR ON ALL THREE DEVICES IS IN THE POST T2 DEPLOYMENT POSITION INDICATING A COMPLETE DEPLOYMENT. DEVICES WERE FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, EACH DEVICE FUNCTIONED AS INTENDED. NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR OF A POSTERIOR HORN FULL THICKNESS TEAR IT WAS REPORTED THAT WHEN HE TIGHTENED DOWN THE SUTURE THE IMPLANT PULLED OUT OF THE MENISCUS. HE REMOVED THE FAILED IMPLANT AND PROCEEDED TO USE ANOTHER WHICH ALSO PULLED OUT THE SAME WAY WHILE TIGHTENING IT DOWN. ANOTHER DEVICE WAS USED AND HAD THE SAME ISSUE. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE. NOTHING WAS LEFT IN THE PATIENT AND ALL DEBRIS WAS REMOVED. THERE WERE TWO ANCHORS THAT HELD AND THE DOCTOR FELT COMFORTABLE WITH THE REPAIR. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617060 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50497476

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR