BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED, EI

    MDR report key: 5975931 · Received September 24, 2016

    Report

    Report Number
    1219602-2016-01063
    Event Type
    Malfunction
    Date Received
    September 24, 2016
    Date of Event
    November 12, 2013
    Report Date
    November 12, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE APPEARS TO NOT HAVE BEEN USED. NO VISIBLE DAMAGE WAS NOTED TO THE PARTS RETURNED. THE DEVICE IMPLANTS WERE ABLE TO BE DEPLOYED WITHOUT ISSUES. THE COMPLAINT COULD NOT BE CONFIRMED; AND A ROOT CAUSE IS NOT ABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS AND COMPLAINT FILES CONFIRMED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED AND NO ABNORMALITIES WERE NOTED DURING THE MANUFACTURING PROCESS FOR THIS LOT. AFTER THE EVALUATION A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A KNOT IN THE SUTURE WHEN THE TWO T-BARS WERE DEPLOYED. ALL PARTS OF THE DEVICE WERE REMOVED AND NONE REMAINED IN THE PATIENT. THERE WERE NO REPORTED PATIENT INJURIES. NO OTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627068 ULTRA FAST-FIX ASSEMBLY - CURVED, EI SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50467664

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR