BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 4882772 · Received July 1, 2015

    Report

    Report Number
    1219602-2015-00210
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    December 24, 2013
    Report Date
    July 1, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT MODE, "PREMATURE DEPLOYMENT". ONLY THE DELIVERY DEVICE WAS RETURNED. THE DEVICE CYCLES AND ACTUATES AS INTENDED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. PER RESULTS OF THE INVESTIGATION NO ROOT CAUSE COULD BE DETERMINED. AT THIS TIME NO FURTHER INVESTIGATION IS WARRANTED. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR PROCEDURE IT WAS REPORTED THAT UPON INSERTION OF THE FIRST ANCHOR WHEN THE LEVER WAS PUSHED BOTH ANCHORS DEPLOYED. A BACKUP DEVICE WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426713 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50433681

    Patients

    Seq Age Sex Outcome Treatment
    1