BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 5068983 · Received September 10, 2015

    Report

    Report Number
    1219602-2015-00969
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT IS DEEMED AS NON-REPORTABLE. DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR 803.3. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE DEVICE REPORTED IS FACILITY STOCK. THE FACILITY DID NOT UTILIZE THE PRODUCT DURING A PROCEDURE. THIS REPORTED EVENT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT PER 21 C.F.R. 803.3. THIS REPORTED EVENT IS DEEMED NON-REPORTABLE.

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR IT WAS REPORTED THAT THE SECOND IMPLANT WOULD NOT FIRE. THIS CAUSED A THREE TO FIVE MINUTE DELAY IN THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600104 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50552285

    Patients

    Seq Age Sex Outcome Treatment
    1