BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM

    MDR report key: 4180961 · Received October 17, 2014

    Report

    Report Number
    1219602-2014-00299
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR EVALUATION. THE PACKAGING MATERIALS AS WELL AS THE T¿S AND SUTURE WERE NOT RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED AND NO ISSUES WERE IDENTIFIED. THE DEVICE WAS RETURNED WITH THE GREY DEPLOYMENT KNOB IN THE FULLY DEPLOYED POSITION. THE DEPTH STRAW WAS REMOVED AND THE DEVICE SHAFT WAS IDENTIFIED TO BE IN EXCELLENT CONDITION AS NO BENDING OR DAMAGE WAS OBSERVED. THE DEVICE WAS FUNCTIONALLY TESTED AND ACTUATED SMOOTHLY WITH NO ISSUE. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE DETAILS OF THE CASE THAT WERE REPORTED THE FAILURE MODE IS CONFIRMED TO BE T2 PRE-DEPLOYMENT. AN INVESTIGATION HAS BEEN INITIATED REGARDING T2 PREMATURE DEPLOYMENT. THE ROOT CAUSE OF THE FAILURE HAS BEEN IDENTIFIED TO BE DESIGN RELATED; SPECIFICALLY THE SUTURE LENGTH BETWEEN THE TWO IMPLANTS AS SPECIFIED PER THE PRINT IS NOT OPTIMAL. THE RESULT IS T2 IS STRIPPED OFF THE NEEDLE INTO THE JOINT SPACE AS THE SURGEON IS IN PROCESS OF MANEUVERING THE INTRODUCER INTO THE MENISCUS PRIOR TO DEPLOYMENT. CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED AND ARE UNDERWAY. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A KNEE ARTHROSCOPY UTILIZING THE FAST-FIX 360 CURVED DELIVERY SYSTEM IT WAS REPORTED THAT THE SURGEON TRIED TO REPAIR THE POSTERIOR TEAR. THE FIRST T-IMPLANT WAS DEPLOYED SUCCESSFULLY, HOWEVER WHEN HE TRIED TO PUT THE NEEDLE AGAIN, THE SECOND T-IMPLANT DROPPED OUT BEFORE HE COULD DEPLOY. THE 1ST T-IMPLANT WAS LEFT INSIDE PATIENT'S KNEE. THE 2ND T-IMPLANT WITH THE SUTURE WAS REMOVED FROM THE PATIENT. ANOTHER FASTFIX 360 WAS USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663362 FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 50517386

    Patients

    Seq Age Sex Outcome Treatment
    1