BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED

    MDR report key: 5034325 · Received August 27, 2015

    Report

    Report Number
    1219602-2015-00919
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 30, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K072322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THREE CURVED ULTRA FAST-FIX ASSEMBLIES WERE RETURNED FOR EVALUATION. THE DEVICES BELONG TO THREE SEPARATE COMPLAINTS AND WERE RETURNED IN ONE PACKAGE; AS A RESULT THE EVALUATION WILL BE ADDED TO EACH COMPLAINT INVESTIGATION. VISUAL ASSESSMENT OF ALL THREE DEVICES SHOWED THE TRIGGERS HAS BEEN FULLY ADVANCED AND ARE LOCKED WITHIN THE HANDLE INDICATING A COMPLETE DEPLOYMENT. NO TS OR SUTURE WERE RETURNED. THE DEPTH LIMITER HAS BEEN TRIMMED TO THE SURGEONS DESIRED LENGTH. DIMENSIONAL INSPECTION OF THE NEEDLES CRIMP, DIMPLE AND RAILGAP CONFIRMED THEY MET PRINT SPECIFICATIONS. TWO OF THE THREE DEVICES ARE BENT. PER THE DEVICE IFU UNDER WARNINGS ¿DO NOT BEND DELIVERY NEEDLE¿. PRIOR TO USE THE FOAM TRIGGER GUARD WAS NOTED TO BE OUT OF PLACE ON THE HANDLE. ALTHOUGH THIS FLAW WAS NOTED THE SURGEON DECIDED TO PROCEED WITH THE USE OF THESE DEVICES. THE INSTRUCTIONS FOR USE STATES UNDER PRECAUTIONS ¿PRIOR TO USE, INSPECT THE DEVICE TO ENSURE IT IS NOT DAMAGED. DO NOT USE A DAMAGED DEVICE¿. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR BOTH IMPLANTS PREMATURELY DEPLOYED. THE SURGEON WAS PERFORMING AN ANTERIOR CRUCIATE LIGAMENT AND MEDIAL MENISCUS REPAIR. DURING THE PROCEDURE, THERE WAS FOAM ON THE ULTRA FAST-FIX, WHICH WAS PLACED BEFORE THE TRIGGER TO PROTECT UNINTENTIONALLY DEPLOYMENT OF A T-IMPLANT. IT WAS REPORTED THAT WHEN ULTRA FAST FIX WAS TAKEN AWAY FROM THE PACK, THE SURGEON NOTICED THE FOAM WAS OUT OF THE PLACE IT SHOULD BE SO HE PLACED THE FOAM IN THE PLACE MANUALLY, WHERE IT IS ORIGINALLY PLANNED AND FOLLOWED THE PROCEDURE. AFTER FIRST DEPLOYMENT OF A T-IMPLANT, WITH THE FOAM IN PLACE AND NOT TOUCHING THE TRIGGER, 2 T-IMPLANTS FELL OF THE NEEDLE. THE SURGEON GRABBED ANOTHER TWO ULTRA FAST FIX, WHICH HAD THE SAME PROBLEM. FOAM WAS OUTSIDE THE ULTRA FAST FIX, AND AGAIN 2 T-IMPLANTS FELL OF THE NEEDLE AFTER FIRST DEPLOYMENT. AFTER FOURTH ATTEMPT, HE SUCCESSFULLY FINISHED THE PROCEDURE. IT WAS CONFIRMED THAT ALL DEBRIS WAS REMOVED, AND NO IMPLANT REMAINED IN THE PATIENT UNSUPPORTED. ANOTHER FAST-FIX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE PROCEDURAL DELAY. THE PATIENT WAS NOTED TO BE OKAY POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569800 ULTRA FAST-FIX ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50393075

    Patients

    Seq Age Sex Outcome Treatment
    1