BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 4943031 · Received July 27, 2015

    Report

    Report Number
    1219602-2015-00490
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 30, 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

    EVALUATION, RESULT: NO TS OR SUTURE WERE RETURNED; FAILURE MODE CANNOT BE CONFIRMED. PRODUCT EVALUATION: ONE FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEMS WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE SHOWED THE ACTUATOR IS IN ITS PRE T2 DEPLOYMENT POSITION INDICATING A DEPLOYMENT OF T1. DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, DEVICE FUNCTIONED AS INTENDED. ALTHOUGH THE FAILURE MODE CANNOT BE CONFIRMED, A CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH THIS MANUFACTURED LOT CONFIRMED THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    DURING A POSTERIOR MEDICAL MENISCUS REPAIR, IT WAS REPORTED THAT T1 DID NOT PASS FROM MENISCUS AND THE T2 IMPLANT CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487784 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50550730

    Patients

    Seq Age Sex Outcome Treatment
    1