BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 7971972 · Received October 16, 2018

    Report

    Report Number
    1219602-2018-01403
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 31, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 72202468 FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM DEVICE RECEIVED. THE COMPLAINT STATED: "IT WAS REPORTED THAT AFTER T1 WAS DEPLOYED, T2 FAILED TO DEPLOYED. THE T1 WAS FIXED BEHIND THE JOINT CAPSULE, AND THE T2 WAS FREE IN THE JOINT CAVITY AND THEN REMOVED BY A PLANER. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY. NO PATIENT INJURIES REPORTED." T1, T2 AND SUTURE WERE NOT RETURNED. THE DEPTH LIMITER WAS IN POSITION. THE DEVICE SHOWS NO DAMAGE. THERE IS NO APPARENT TWISTING OR BENDING OF THE DELIVERY NEEDLE. NO MECHANICAL PROBLEM WAS FOUND. A FUNCTIONAL TEST CONFIRMED THAT THE DEVICE DELIVERY SYSTEM CYCLED AND ADVANCED AS EXPECTED. SEVERAL FACTORS INFLUENCING SUCCESSFUL ANCHORING INCLUDE DEVICE ABILITY, IMPLANT LOCATION AND TISSUE CONDITION. IT IS UNDETERMINED WHICH FACTORS CONTRIBUTED TO STATED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER T1 WAS DEPLOYED, T2 FAILED TO DEPLOYED. THE T1 WAS FIXED BEHIND THE JOINT CAPSULE, AND THE T2 WAS FREE IN THE JOINT CAVITY AND THEN REMOVED BY A PLANER. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY. NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812948 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50705494

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR