BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 22290545 · Received June 19, 2025

    Report

    Report Number
    1219602-2025-01513
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 27, 2025
    Report Date
    October 1, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED TWO DEVICES WERE EACH RETURNED IN ORIGINAL PACKAGING WITH BATCH NUMBER 2143194 ON THE LABELS. DEVICE ONE, BOTH IMPLANTS HAVE BEEN DEPLOYED AND THE T1 PLACED BACK INTO THE TIP OF THE NEEDLE. THE SUTURE KNOT IS TIGHTENED DOWN. THE ACTUATOR IS IN THE PRE-T2 POSITION. BIO DEBRIS IS PRESENT. DEVICE TWO THE T1, T2, AND SUTURE WERE NOT RETURNED. THE ACTUATOR IS AT THE TIP OF THE NEEDLE. THE NEEDLE ASSEMBLY IS SEVERELY BENT. BIO DEBRIS IS PRESENT. A FUNCTIONAL EVALUATION OF DEVICE ONE REVEALED THE ACTUATOR WILL CYCLE BUT THE ACTUATOR ATTEMPTS TO STICK AT THE TIP AND REQUIRES MANIPULATION BEFORE RETURNING TO THE NEXT PRE-DEPLOYMENT POSITION. DEVICE TWO THE ACTUATOR WILL NOT CYCLE AND REMAINS STUCK AT THE TIP OF THE NEEDLE. AN IMAGE EVALUATION WAS PERFORMED AND FOUND ONE INSERTION DEVICE ON TOP OF ITS PACKAGING; THE ANCHORS ARE NOT VISIBLE. A SECOND IMAGE FOUND ANOTHER FAST FIX DEVICE ON TOP OF ITS PACKAGING; THE ANCHOR IS ATTACHED TO THE SUTURE BUT IS OUTSIDE THE NEEDLE. THE PART AND LOT NUMBERS ARE VISIBLE AND MATCH THE REPORTED INFORMATION. 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 SURGERY, AFTER T1 WAS DEPLOYED, THE NEEDLE OF TWO (2) FAST-FIX 360 COULD NOT SPRING BACK TO FIRE THE T2. T1 WAS SUCCESSFULLY REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724274 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2143194

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown