BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 5451104 · Received February 22, 2016

    Report

    Report Number
    1219602-2016-00095
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 18, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION NARRATIVE - ONE FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM LOT 5051756 WERE RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE SHOWS THE INSERTION NEEDLE IS TWISTED AND IS BENT ON TWO PLANES. DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, DEVICE WOULD NOT FUNCTION PROPERLY DUE TO THE AFOREMENTIONED DAMAGE. NO TS OR SUTURE WERE RETURNED FOR EXAMINATION. REPORTED NON-DEPLOYMENT COULD NOT BE CONFIRMED. PER THE DEVICE IFU UNDER WARNINGS ¿DO NOT BEND THE DELIVERY NEEDLE. THE FAST-FIX 360 DEVICES ARE MANUFACTURED WITH STRAIGHT OR CURVED DELIVERY NEEDLES. INTENTIONAL BENDING OF THE DELIVERY NEEDLE MAY MAKE IT DIFFICULT OR IMPOSSIBLE TO DELIVER THE T1 AND T2 IMPLANTS. IF THE DELIVERY NEEDLE HAS BEEN INADVERTENTLY BENT, OR IF RESISTANCE IS ENCOUNTERED DURING DEPLOYMENT, A NEW DELIVERY DEVICE MAY BE NEEDED¿. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FAST-FIX 360 T1 IMPLANT FIRED BUT T2 DID NOT. A BACKUP DEVICE WAS REPORTEDLY USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THE CUSTOMER REPORTED THAT THEY WERE ABLE TO COMPLETELY REMOVE THE ANCHORS AND THEY DID NOT HAVE TO MAKE AN ADDITIONAL INCISION." THERE IS NO REPORT OF PATIENT INJURY AS A RESULT OF THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107734 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50571756

    Patients

    Seq Age Sex Outcome Treatment
    1