BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYSTEM

    MDR report key: 5033339 · Received August 26, 2015

    Report

    Report Number
    1219602-2015-00924
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 17, 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

    FOUR USED DEVICES WERE RETURNED FOR EVALUATION. THE DEVICES WERE RETURNED WITH SUTURES AND ANCHORS. THE DEVICES WERE VISUALLY EVALUATED AND NO ISSUES WERE IDENTIFIED. THE DEPTH STRAWS OF ALL FOUR USED DEVICES HAVE BEEN TRIMMED TO THE SURGEON¿S DESIRED LENGTH. THE DEVICES WERE FUNCTIONALLY TESTED AND ACTUATED WITH NO ISSUE. REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. THE FAILURE MODE COULD NOT BE CONFIRMED, AND THE ROOT CAUSE CANNOT BE DETERMINED. DUE TO THIS FACT IT IS NOT POSSIBLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LATERAL MENISCUS REPAIR PROCEDURE USING FAST-FIX 360 CURVED NDL DELIVERY SYSTEM BOTH T1 AND T2 IMPLANTS DEPLOYED AT THE SAME TIME. THE IMPLANTS WERE REMOVED FROM THE PATIENT AND NO PIECE OR DEBRIS REMAINED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THIS INCIDENT DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566488 FAST-FIX 360 CURVED NDL DELIVERY SYSTEM SUTURE, NONABSORBABLE, SYNTHETIC, PE GAT SMITH & NEPHEW, INC. 50527700

    Patients

    Seq Age Sex Outcome Treatment
    1