BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 9936410 · Received April 8, 2020

    Report

    Report Number
    1219602-2020-00610
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 7, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEMS, USED IN TREATMENT, HAVE BEEN RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF SAMPLE LOT 2042802 SHOWED NO SUTURE OR TS REMAIN ON THE DELIVERY NEEDLE BUT WERE RETURNED FOR EVALUATION. EXAMINATION OF THE CONSTRUCT SHOWED T1 DISTAL END HAS BEEN BROKEN OFF AND NOT RETURNED, THE SUTURE HAS BEEN CINCHED AND T2 SHOWS NO ABNORMALITIES. THE NEEDLE IS DRAMATICALLY BENT ON TWO PLANES. DEVICE WAS FUNCTIONALLY TESTED FOR PROPER ACTUATOR ADVANCEMENT AND CYCLING, THE DEVICE WOULD NOT FUNCTION PROPERLY DUE TO THE BENT NEEDLE. PER THE DEVICE INSTRUCTIONS FOR USE UNDER WARNING: ¿DO NOT BEND THE DELIVERY NEEDLE. THE FAST-FIX 360 DEVICES ARE MANUFACTURED WITH STRAIGHT OR CURVED DELIVERY NEEDLES. INTENTIONAL BENDING OF THE DELIVERY NEEDLE MAY MAKE IT DIFFICULT OR IMPOSSIBLE TO DELIVER THE T1 AND T2 IMPLANTS. IF THE DELIVERY NEEDLE HAS BEEN INADVERTENTLY BENT, OR IF RESISTANCE IS ENCOUNTERED DURING DEPLOYMENT, A NEW DELIVERY DEVICE MAY BE NEEDED¿. A REVIEW OF THE MANUFACTURING AND COMPLAINT RECORDS WAS PERFORMED FOR THIS LOT, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MENISCAL REPAIR, THE FASTFIX 360 DID NOT DEPLOY T2. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401985 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2042802

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR