BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 24658870 · Received March 22, 2026

    Report

    Report Number
    1219602-2026-00828
    Event Type
    Malfunction
    Date Received
    March 22, 2026
    Date of Event
    February 6, 2026
    Report Date
    May 11, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE CASE-(B)(4). H2: ADDITIONAL INFORMATION: B5 AND H6.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4)

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE (B)(4). H2: ADDITIONAL INFORMATION: H6: MEDICAL DEVICE PROBLEM CODE. H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION WITH OTHER DEVICES. A VISUAL INSPECTION REVEALED THAT TEN FAST-FIX OF LOT 2191498 WERE RETURNED TOGETHER: SEVEN UNOPENED/SEALED UNITS, AND THREE OPENED/USED UNITS WERE RETURNED. EACH OF THE OPENED DEVICES CAME WITH ORIGINAL LABELING WITH THE LOT NUMBER ON THEM, AND PRESENTED BIO DEBRIS. FOR DEVICE ONE THE T1, T2, AND SUTURE WERE NOT RETURNED, AND THE NEEDLE ASSEMBLY IS BENT. FOR DEVICE TWO THE T1, T2, AND SUTURE WERE NOT RETURNED, THE NEEDLE ASSEMBLY IS BENT, AND THE ACTUATOR IS AT THE TIP OF THE NEEDLE. FOR DEVICE THREE THE T1, T2, AND SUTURE WERE RETURNED ON THE NEEDLE, THE T1 HAS BEEN PLACED BACK ON THE TIP OF THE NEEDLE, AND THE ACTUATOR IS IN THE PRE-T2 POSITION. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICES AND FOUND THAT THE ACTUATORS WILL CYCLE BUT THE ACTUATORS ATTEMPTED TO STICK AT THE TIP AND REQUIRED MANIPULATION BEFORE RETURNING TO THE NEXT PRE-DEPLOYMENT POSITION. 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. OTHER FACTOR LINES INCLUDE AN UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE ALLOWING THE DEVICE TO PREMATURELY DEPLOY. 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 KNEE ARTHROSCOPIC PROCEDURE, THE FASTFIX 360'S T2 FELL OUT FROM THE NEEDLE WITHOUT DEPLOYMENT. T1 WAS LEFT SECURED IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, THE FASTFIX 360'S T2 FELL OUT FROM THE NEEDLE WITHOUT DEPLOYMENT. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567201 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2191498 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown