BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 22964484 · Received September 4, 2025

    Report

    Report Number
    1219602-2025-02187
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 25, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE (B)(4). THE RETURNED DEVICES WERE RECEIVED WITHOUT LOT LABELS OR TRACEABILITY INFORMATION. THE DEVICES UNDER INVESTIGATION ARE POTENTIALLY FROM TWO DIFFERENT LOTS: LOT 2173912 (MFG. DATE: 04-JAN-2025; EXP. DATE: 04-JAN-2028) AND LOT 2165965 (MFG. DATE: 01-OCT-2024; EXP. DATE: 01-OCT-2027). DUE TO THE ABSENCE OF LOT IDENTIFICATION, IT WAS NOT POSSIBLE TO DEFINITIVELY ASSIGN EACH DEVICE TO A SPECIFIC LOT. THIS REPORT COVERS DEVICES WITH SPECIFIC MODES OF FAILURE RELATED TO THESE LOTS, BUT WITHOUT DEFINITIVE LOT ASSIGNMENT.

    Additional Manufacturer Narrative · 0

    H4 SHOULD BE READ IN BLANK.

    Additional Manufacturer Narrative · 0

    H11: H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED SEVEN DEVICES WERE RETURNED TOGETHER WITHOUT ANY ORIGINAL PACKAGING FOR LOT IDENTIFICATION. BIO DEBRIS IS PRESENT ON ALL THE DEVICES. DEVICE ONE AND TWO WERE RETURNED WITHOUT THE T1, T2, OR SUTURE. THE ACTUATOR IS IN THE PRE-T1/POST-T2 POSITION. DEVICE THREE WAS RETURNED WITHOUT THE T1, T2, OR SUTURE. THE ACTUATOR IS IN THE PRE-T2 POSITION. DEVICE FOUR WAS RETURNED WITHOUT THE T1, T2, OR SUTURE. THE ACTUATOR IS IN THE PRE-T1/POST-T2 POSITION. DEVICE FIVE THE T1 WAS RETURNED OFF THE NEEDLE BUT ATTACHED TO THE SUTURE. THE T2 AND SUTURE WERE RETURNED ON THE NEEDLE. THE ACTUATOR IS IN THE PRE-T2 POSITION. DEVICES SIX AND SEVEN THE T1 WAS RETURNED OFF THE NEEDLE BUT ATTACHED TO THE SUTURE. THE T2 AND SUTURE WERE RETURNED ON THE NEEDLE. THE ACTUATOR IS IN THE PRE-T1/POST-T2 POSITION. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THAT DEVICES ONE AND TWO WILL CYCLE BUT ATTEMPT TO STICK AT THE TIP REQUIRING MANIPULATION TO RETURN TO THE NEXT PRE-DEPLOYMENT POSITION. DEVICE THREE CYCLES AS INTENDED. DEVICE FOUR WILL CYCLE BUT ATTEMPTS TO STICK AT THE TIP REQUIRING MANIPULATION TO RETURN TO THE NEXT PRE-DEPLOYMENT POSITION. DEVICE FIVE REVEALED THE ACTUATOR CYCLED THE T2 OFF THE NEEDLE, BUT THE ACTUATOR ATTEMPTS TO STICK AT THE TIP AND REQUIRES MANIPULATION BEFORE RETURNING TO THE NEXT PRE-DEPLOYMENT POSITION. DEVICES SIX AND SEVEN, THE ACTUATOR CYCLED TO THE TIP, RETURNING TO THE PRE-T2 POSITION, THEN CYCLED THE T2 OFF THE NEEDLE, AND CONTINUED TO CYCLE AS INTENDED. 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 ARTHROSCOPIC REPAIR, FOUR (4) FAST-FIX 360 DEVICES ENCOUNTERED PROBLEMS WHEN PLACING THE MENISCUS SUTURES. THE SURGERY 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
    1876508 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown