BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 25069085 · Received May 4, 2026

    Report

    Report Number
    1219602-2026-01320
    Event Type
    Malfunction
    Date Received
    May 4, 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: (B)(4) H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED ONE (1) OPENED/USED DEVICE OF LOT 2190096 WAS RETURNED IN ORIGINAL PACKAGING WITH THE LOT NUMBER 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 IN THE PRE-T2 POSITION. THE INSERTION DEVICE HAS NO VISIBLE DEFECT. BIO DEBRIS IS PRESENT. A FUNCTIONAL EVALUATION SHOWED THE ACTUATOR WILL CYCLE BUT MOVES BENEATH THE T2 AND WILL NOT ACTUATE IT OFF THE NEEDLE. 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.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED ONE (1) OPENED/USED DEVICE OF LOT 2190096 WAS RETURNED IN ORIGINAL PACKAGING WITH THE LOT NUMBER 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 IN THE PRE-T2 POSITION. THE INSERTION DEVICE HAS NO VISIBLE DEFECT. BIO DEBRIS IS PRESENT. A FUNCTIONAL EVALUATION SHOWED THE ACTUATOR WILL CYCLE BUT MOVES BENEATH THE T2 AND WILL NOT ACTUATE IT OFF THE NEEDLE. 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 KNEE ARTHROSCOPIC PROCEDURE, THE LOADING MECHANISM OF A FAST-FIX 360 DEVICE DID NOT WORK PROPERLY, AS T2 WAS NOT IN THE USUAL POSITION BEFORE 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
    10140 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2190096 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown