BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 7339801 · Received March 14, 2018

    Report

    Report Number
    1219602-2018-00333
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 19, 2018
    Report Date
    May 9, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE HAS NOT BEEN RETURNED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE RETURN OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THREE USED FAST-FIX 360 CURVED NEEDLE DELIVERY INSERTERS WERE RETURNED FOR EVALUATION. NO TS OR SUTURES WERE RETURNED. DEVICES WERE RETURNED IN THE SAME PACKAGING MAKING LOT IDENTIFICATION PROHIBITIVE. THE DEVICES BELONG TO COMPLAINTS. C-0181163, C-0181578 AND C-0181591. VISUAL ASSESSMENT OF SAMPLE (A) SHOWED THE NEEDLE IS BENT. THE DEVICES ACTUATOR IS IN ITS POST T2 DEPLOYMENT POSITION INDICATING A COMPLETE DEPLOYMENT. DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, DEVICE FUNCTIONED AS INTENDED. VISUAL ASSESSMENT OF SAMPLE (B) SHOWED NO ABNORMALITIES. THE DEVICES ACTUATOR IS IN ITS POST T2 DEPLOYMENT POSITION INDICATING A COMPLETE DEPLOYMENT. DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, DEVICE FUNCTIONED AS INTENDED. VISUAL ASSESSMENT OF SAMPLE (C) SHOWED THE NEEDLE IS BENT. THE DEVICES ACTUATOR IS IN ITS POST T2 DEPLOYMENT POSITION INDICATING A COMPLETE DEPLOYMENT. DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, DEVICE FUNCTIONED AS INTENDED. NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CAN BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEPLOYING THE FIRST ANCHOR, THE SECOND ONE DID NOT UNFOLD AND THE SUTURE IS LOST. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181732 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 50693625 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1