BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 STRAIGHT NDL DELIVERY SYSTEM

    MDR report key: 4926420 · Received July 20, 2015

    Report

    Report Number
    1219602-2015-00390
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    January 30, 2015
    Report Date
    July 16, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE DEVICE HAS NOT BEEN RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. DUE TO THE DEVICE NOT BEING RETURNED A ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE USING FAST-FIX 360 STRAIGHT NDL DELIVERY SYSTEM T1 DETACHED FROM THE SUTURE WHEN IT WAS PULLED TO TENSION IT. BOTH T1 AND T2 IMPLANTS DEPLOYED PROPERLY. T1 WAS REMOVED FROM THE PATIENT. THERE WAS A PROCEDURAL DELAY OF 1 MINUTE. 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
    470143 FAST-FIX 360 STRAIGHT NDL DELIVERY SYSTEM SUTURE, NONABSORBABLE, SYNTHETIC, PE GAT SMITH & NEPHEW, INC. 50532757

    Patients

    Seq Age Sex Outcome Treatment
    1