BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FF 360

    MDR report key: 3790006 · Received May 5, 2014

    Report

    Report Number
    1219602-2014-00147
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MARKED AS AVAILABLE FOR EVALUATION ; ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT YET BEEN RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE FAST-FIX 360 CURVED NDL DELIVERY SYS DEVICE WAS RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT MODE, ¿T2 PRE-DEPLOYED.¿ THE INSERTION NEEDLE WITH NO IMPLANTS OR SUTURE CONSTRUCT WAS RECEIVED. THE DEVICE IS VISIBLY BENT. THE ACTUATOR WOULD NOT FUNCTION DUE TO THE BEND IN THE NEEDLE SHAFT. NO ROOT CAUSE RELATED TO THE MANUFACTURING CAN BE ESTABLISHED AND NO FURTHER ACTION IS REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. THE INSTRUCTION FOR USE (IFU) STATES: ¿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.¿ (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCUS REPAIR USING A FAST-FIX 360 CURVED NDL DELIVERY SYS, IT WAS REPORTED THAT BOTH IMPLANTS DEPLOYED SIMULTANEOUSLY. WHEN THE SURGEON PUSHED THE SLIDER TO DEPLOY T1, T2 ALSO CAME OUT WITH T1. THE IMPLANTS WERE LEFT IN THE JOINT UNSUPPORTED. A BACKUP DEVICE WAS AVAILABLE FOR THE CASE. THERE WERE NO REPORTS OF PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269312 FF 360 FAST-FIX 360 CURVED NDL DELIVERY SYS GAT MANSFIELD MANUFACTURING SITE 72202468 50491173

    Patients

    Seq Age Sex Outcome Treatment
    1