BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 STRAIGHT NDL DELIVERY SY

    MDR report key: 4960077 · Received August 3, 2015

    Report

    Report Number
    1219602-2015-00647
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE, INCLUDING IMPLANTS AND SUTURE, WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE DEVICE FOUND NO DAMAGE AND THE IMPLANTS APPEARED NORMAL. THE DEVICE WAS ACTUATED WITHOUT DIFFICULTY. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS UNABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. THERE WERE NO INTERNAL PROCESSING ISSUES WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING A FAST-FIX 360 STRAIGHT NEEDLE DELIVERY SYSTEM AFTER DEPLOYING THE T1 ANCHOR INSIDE THE MENISCUS AND ATTEMPTING TO DEPLOY T2, THE T1 ANCHOR CAME LOOSE. THE SURGEON PULLED THE DEVICE OUT OF THE JOINT AND NO IMPLANTS WERE LEFT INSIDE THE JOINT. INFORMATION RECEIVED ON FOLLOW UP INDICATES THAT THERE WAS NO ADDITIONAL DAMAGE DONE AND THE SUTURE DID NOT BREAK OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505374 FAST-FIX 360 STRAIGHT NDL DELIVERY SY SUTURE, NONABSORBABLE, SYNTHETIC, PE GAT SMITH & NEPHEW, INC. 50438109

    Patients

    Seq Age Sex Outcome Treatment
    1