BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 4964002 · Received August 4, 2015

    Report

    Report Number
    1219602-2015-00673
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION WHERE PRODUCT INVESTIGATION REVEALED THAT THE ALLEGATION COULD NOT BE CONFIRMED AS THE INSERTION DEVICE WAS RECEIVED WITHOUT THE SUTURE OR IMPLANTS. THE ACTUATOR WAS NOTED TO NOT BE FUNCTIONING. THERE IS ALSO A BEND IN THE INSERTER SHAFT. PER IFU 10600499, ¿THE FAST-FIX 360 DEVICES ARE MANUFACTURED WITH STRAIGHT OR CURVED DELIVERY NEEDLES. INTENTIONAL BENDING OF THE DELIVERY NEEDLE MAY MAKE IT DIFFICULT OR IMPOSSIBLE TO DELIVER THE T1 AND T2 IMPLANTS. IF THE DELIVERY NEEDLE HAS BEEN INADVERTENTLY BENT, OR IF RESISTANCE IS ENCOUNTERED DURING DEPLOYMENT, A NEW DELIVERY DEVICE MAY BE NEEDED.¿ THE ACTUAL ROOT CAUSE OF THE REPORTED COMPLAINT WAS NOT ABLE TO BE DETERMINED. 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. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT WHILE USING A FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM THE DEVICE DID NOT FIRE. FOLLOW UP INFORMATION REVEALED THAT THE SURGEON WAS ABLE TO DEPLOY THE FIRST IMPLANT WITHOUT DIFFICULTY, HOWEVER, THE SECOND IMPLANT WOULD NOT DEPLOY. THE SURGEON WAS ABLE TO REMOVE THE FIRST IMPLANT, NOTHING WAS LEFT FREE FLOATING IN THE JOINT. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511087 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, PE GAT SMITH & NEPHEW, INC. 50485690

    Patients

    Seq Age Sex Outcome Treatment
    1