BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 5020998 · Received August 21, 2015

    Report

    Report Number
    1219602-2015-00884
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 14, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITHOUT THE ANCHORS OR SUTURES FOR EVALUATION. THE DEVICE WAS RECEIVED WITH THE ACTUATOR IN THE T1 PRE-DEPLOYMENT POSITION. THE DEVICE WAS VISUALLY EVALUATED AND THE NEEDLE SHAFT IS IN GOOD CONDITION. THE DEPTH STRAW HAS BEEN TRIMMED TO THE SURGEON¿S DESIRED LENGTH. THE DEPTH STRAW WAS REMOVED, AND THE SUTURE RETENTION TUBE HAS MOVED 180 DEGREES FROM THE ORIGINAL PLACEMENT LOCATION. THIS OCCURRED POST ASSEMBLY AS THE WITNESS MARKS FROM THE TAIL OF THE ANCHOR IS PRESENT ON THE RETENTION TUBE. ALSO THE TUBE WAS ABLE TO BE EASILY ROTATED BY HAND WHICH IS SOMEWHAT UNUSUAL, BUT WOULD NOT HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE DEVICE WAS FUNCTIONALLY TESTED AND OPERATED WITH NO ISSUES. THE CONDITION OF THE DEVICE IS CONSISTENT WITH A DEVICE THAT HAS BEEN FULLY ACTUATED DUE TO THE POSITION OF THE ACTUATOR ROD AND THE LACK OF IMPLANTS AND SUTURE RETURNED FOR EVALUATION. THE CONDITION OF THE DEVICE IS CONTRARY TO THE REPORT THAT T2 COULD NOT BE DEPLOYED. A REVIEW OF THE NONCONFORMANCE DATABASE DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURE OF THE LOT. THE FAILURE MODE IS UNCONFIRMED, AND THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, IT WAS REPORTED THAT IT WAS POSSIBLE TO PLACE THE T1 IMPLANT, BUT NOT THE T2 IMPLANT. IT WAS CONFIRMED THAT T1 DID NOT REMAIN IN THE JOINT. IT WAS CONFIRMED THAT ALL DEBRIS WAS REMOVED, AND NOTHING REMAINED IN THE PATIENT. THE TYPE OF PROCEDURE BEING PERFORMED, AND THE TYPE OF PORTAL APPROACH IS UNKNOWN. AFTER THE FAILURE OF THE FAST-FIX, THE SURGEON USED ANOTHER FAST-FIX. THERE WAS A DELAY OF 20 MINUTES TO THE PROCEDURE. THE PATIENT WAS REPORTED TO BE OKAY POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555137 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50525619

    Patients

    Seq Age Sex Outcome Treatment
    1