BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 5022671 · Received August 21, 2015

    Report

    Report Number
    1219602-2015-00894
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    April 10, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ONE FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE SHOWED T1 IS FREE FROM THE INSERTION NEEDLE. THE ACTUATOR IS IN ITS T2 PRE-DEPLOYMENT POSITION CONFIRMING A TRIGGER ADVANCEMENT AND DEPLOYMENT OF T1. THE DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING AND WAS FOUND TO FUNCTION 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

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR, WHEN THE SURGEON DECIDED TO CHANGE THE PLACE FOR T1 FIRST IMPLANT, IT WENT OFF THE NEEDLE AND CAME OUT THROUGH MENISCUS, BACK TO THE JOINT SPACE. THERE WAS A FIVE MINUTE PROCEDURAL DELAY WITH NO REPORTED PATIENT INJURIES OR COMPLICATIONS. A BACKUP DEVICE WAS AVAILABLE. IT WAS CONFIRMED THAT NO FRAGMENTS LEFT IN PATIENT. THERE WAS A 5 MINUTE PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556481 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50538469

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR