BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 24310718 · Received February 10, 2026

    Report

    Report Number
    1219602-2026-00428
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    July 29, 2025
    Report Date
    February 10, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: CASE- (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE DEVICE WAS RETURNED IN ORIGINAL PACKAGING WITH BATCH NUMBER 2150417 ON THE LABEL. THE T1 WAS RETURNED OFF THE NEEDLE BUT ATTACHED TO THE SUTURE. THE T2 AND SUTURE WERE RETURNED ON THE NEEDLE. THE ACTUATOR IS AT THE TIP OF THE NEEDLE. THE NEEDLE ASSEMBLY IS BENT. BIO DEBRIS IS PRESENT. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THE ACTUATOR WILL NOT CYCLE AND REMAINS STUCK AT THE TIP OF THE NEEDLE. AN EVALUATION OF THE IMAGE PROVIDED BY THE CUSTOMER FOUND THE SHAFT AND TIP OF THE INSERTION DEVICE; HOWEVER, THE ANCHORS ARE NOT VISIBLE. THE PACKAGING IS NEXT TO WHAT APPEARS TO BE A PIECE OF SUTURE. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. DURING THE INVESTIGATION IT WAS NOT POSSIBLE TO IDENTIFY A DEFINITIVE ROOT CAUSE; HOWEVER, IT WAS CONCLUDED THAT THE POTENTIAL CAUSES FOR THE REPORTED EVENT INCLUDE (1) THE APPLICATION OF UNINTENDED, INAPPROPRIATE, OR EXCESSIVE FORCE DURING DEVICE USE, AND (2) USER FAILURE TO FULLY ACTUATE THE DEVICE DURING THE IMPLANTATION PROCESS. THE RISK MANAGEMENT REVIEW CONFIRMED THAT THE REPORTED FAILURE IS APPROPRIATELY DOCUMENTED. THE OVERALL RISK LEVEL IS CONSIDERED ADEQUATE. THEREFORE, NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A MENISCUS SUTURE PROCEDURE, THE T-IMPLANT OF A FAST-FIX 360 WAS NOT DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. 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
    372019 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2150417 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown