BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 21850413 · Received April 16, 2025

    Report

    Report Number
    1219602-2025-00905
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    June 28, 2024
    Report Date
    April 16, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION ALONG WITH TWO MORE DEVICES FROM THE SAME PART NUMBER. A VISUAL INSPECTION REVEALED THEY WERE RETURNED TOGETHER IN ONE ORIGINAL PACKAGING WITH THE BATCH NUMBER 2103014 ON THE LABEL. THERE WERE NO IMPLANTS OR SUTURES RETURNED FOR ANY OF THE DEVICES. THE ACTUATOR FOR TWO DEVICES ARE IN THE PRE-T1/POST-T2 POSITION. THE THIRD DEVICES NEEDLE HAS BEEN DEFORMED AND BROKEN FROM THE DEVICE. BIO DEBRIS IS PRESENT ON ALL THE DEVICES. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THE TWO DEVICES WITH INTACT NEEDLES CYCLED AS INTENDED. A FUNCTION OF THE THIRD DEVICE CANNOT BE PERFORMED DUE TO THE DESTRUCTION OF THE NEEDLE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE PROCEDURAL VARIANCE, OR DEVIATIONS FROM ESTABLISHED PROTOCOLS, INCREASING RISKS AND LEADING TO UNINTENDED CONSEQUENCES. BASED ON THIS INVESTIGATION, THERE IS NO EVIDENCE TO SUGGEST A DESIGN, MATERIAL OR MANUFACTURING ISSUE. THEREFORE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T1 IMPLANT OF THREE (3) FAST FIX WAS BENDING AND COULDN'T BE FIXED AT THE MENISCUS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111471 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2104322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown