BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 4860008 · Received June 22, 2015

    Report

    Report Number
    1219602-2015-00147
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    December 26, 2012
    Report Date
    June 19, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURN FOR EVALUATION. EVALUATION WAS NOT POSSIBLE, AS THE DEVICE IS NOT BEING 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. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. DUE TO THIS FACT WE ARE UNABLE 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 MENISCAL REPAIR PROCEDURE, THE SURGEON WAS USING A FAST-FIX 360 CURVED, INTRA-OPERATIVE IT WAS REPORTED THAT THE DEVICE BROKE, THERE WERE TWO DEVICES, AND EACH HAD SIMULTANEOUS DEPLOYMENT ISSUES. PER THE SERVICE NOTIFICATION NO INJURIES OR COMPLICATION WERE REPORTED AND NO DEVICE BROKE WITHIN THE PATIENT. THERE WAS APPROXIMATELY A 2-5 DELAY TO THE CASE AS A BACKUP DEVICE WAS ON HAND TO COMPLETE THE PROCEDURE. SALES REP CONFIRMED THAT THE ISSUE WAS THAT DURING DEPLOYMENT OF T1, T2 ALSO CAME OFF THE INSERTER. NO T WAS LEFT IN THE PATIENT UNSUPPORTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FAST-FIX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402631 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50421052

    Patients

    Seq Age Sex Outcome Treatment
    1