BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 5111489 · Received September 29, 2015

    Report

    Report Number
    1219602-2015-01047
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    August 1, 2013
    Report Date
    August 28, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVALUATION WAS NOT POSSIBLE, AS THE DEVICES WILL NOT BE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. DUE TO THIS FACT IT IS NOT POSSIBLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. IN THE EVENT SAMPLES ARE RETURNED FOR EVALUATION, THE COMPLAINT WILL BE REOPENED FOR ADDITIONAL INVESTIGATION. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SECOND ANCHOR HAS NOT ADVANCED IN THE GUTTER OF THE NEEDLE DURING THE IMPLEMENTATION OF THE FIRST, SO THE SECOND ANCHOR COULD NOT BE DEPLOYED. NO PIECE OF THE DEVICE BROKE OFF WITHIN THE PATIENT. IT IS UNKNOWN IF THERE WAS A PROCEDURAL DELAY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THIS INCIDENT DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642085 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50460914

    Patients

    Seq Age Sex Outcome Treatment
    1