BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 4973007 · Received August 5, 2015

    Report

    Report Number
    1219602-2015-00709
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 7, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE SHOWED NO T¿S OR SUTURE REMAINS ON THE NEEDLE. NO SUTURE OR TS WERE RETURNED. THE ACTUATOR IS IN ITS T2 PRE-DEPLOYMENT POSITION INDICATING A DEPLOYMENT OF T1 AND PRE-DEPLOYMENT OF T2. THE DEPTH LIMITERS DISTAL END IS DAMAGED/CRUMPLED. DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, DEVICE FUNCTIONED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. AFTER THE EVALUATION, THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    . THE DEVICE WAS MARKED AS AVAILABLE FOR EVALUATION; ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCUS REPAIR, IT WAS REPORTED THAT SURGEON PRESSED THE TRIGGER AND THE FIRST PK DEPLOYED CORRECTLY; HOWEVER, THE SECOND PK DID NOT DEPLOY. THE SURGEON HAD TO REMOVE THE SUTURES. FINALLY, ANOTHER FAST-FIX DEVICE WAS USED AND BOTH PKS DEPLOYED WITHOUT ANY PROBLEM. THE SURGEON USED THE APPROPRIATE TECHNIQUE. THE PATIENT IS REPORTED TO BE OKAY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE IMPLANT DOES NOT REMAIN IN THE PATIENT UNSUPPORTED AND THAT THE SURGEON CONFIDENT THAT ALL DEBRIS WAS REMOVED. THE RED AREA OF THE MENISCUS WAS BEING REPAIRED. THERE WAS A 40 MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515600 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50524322

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR