BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 4896636 · Received July 7, 2015

    Report

    Report Number
    1219602-2015-00243
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    April 12, 2014
    Report Date
    July 6, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE DEVICES WERE RECEIVED FOR EVALUATION OF THE REPORTED COMPLAINT MODE, ¿PRE-DEPLOYMENT¿. BOTH DEVICES WERE RETURNED WITHOUT THE IMPLANTS AND SUTURE. THE INSERTER ROD FOR BOTH DEVICES WAS UNABLE TO BE RETRACTED; THE INSERTER SHAFT WAS FOUND TO BE BENT, WHICH MAY HAVE CAUSED THIS ISSUE. PER THE IFU (1061352). A 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. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FAST-FIX 360 CURVED NDL DELIVERY SYS DEVICE DEPLOYED THE METAL ADVANCE ROD OUT PAST THE TIP OF THE NEEDLE. THE DEVICE WOULD NOT RETRACT AND APPEARED TO HAVE PUSHED BOTH T'S OUT AT ONCE. BOTH IMPLANTS DEPLOYED AT THE SAME TIME ON THE SAME SIDE OF THE MENISCUS, AND BOTH IMPLANTS WERE LOOSE IN THE JOINT. THE IMPLANTS WERE ABLE TO BE REMOVED. THE SURGEON USED ANOTHER FAST-FIX TO COMPLETE THE PROCEDURE, AND THE PATIENT WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437754 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50493917

    Patients

    Seq Age Sex Outcome Treatment
    1