BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 20453057 · Received October 15, 2024

    Report

    Report Number
    1219602-2024-02276
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 9, 2024
    Report Date
    November 14, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). D4, LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: (2144447, 2151328, 2143229, 2138350), HOWEVER, IT IS UNKNOWN THE SPECIFIC LOT NUMBER OF THE THREE DEFECTIVE DEVICES. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE 4 LOT NUMBERS REPORTED: 06-FEB-2027 (LOT NUMBER: (2144447), 12-APR-2027 (LOT NUMBER: 2151328), 17-JAN-2027 (LOT NUMBER: 2143229) & 27-NOV-2026 (LOT NUMBER: (2138350). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE 4 LOT NUMBERS REPORTED: 06-FEB-2024 (LOT NUMBER: (2144447), 12-APR-2024 (LOT NUMBER: 2151328), 17-JAN-2024 (LOT NUMBER: 2143229) & 27-NOV-2023 (LOT NUMBER: (2138350).

    Additional Manufacturer Narrative · 0

    H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THE INVESTIGATION DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, PROBABLE CAUSES FOR THE REPORTED FAILURE IN THIS EVENT COULD INCLUDE: (1) THE APPLICATION OF UNINTENDED, INAPPROPRIATE, OR EXCESSIVE FORCE DURING DEVICE USE, (2) USER FAILURE TO FULLY ACTUATE THE DEVICE DURING THE IMPLANTATION PROCESS, AND (3) TOLERANCE VARIABILITY IN THE BENDING PROCESS BETWEEN THE NEEDLE AND ACTUATOR, WHICH COULD HAVE POTENTIALLY CAUSED THE ACTUATOR TO BECOME STUCK OR SLIDE BELOW THE IMPLANT, PREVENTING IT FROM PROPERLY PICKING UP THE IMPLANT FOR DEPLOYMENT. THE MANUFACTURING PROCESS WAS REVIEWED, AND A PROCESS ENHANCEMENT WAS IMPLEMENTED TO REDUCE THE VARIABILITY IN THE BENDING PROCESS OF THE ACTUATOR AND NEEDLE, THEREBY REDUCING THE RISK OF A STUCK ACTUATOR WITHIN THE NEEDLE. ALTHOUGH THIS POTENTIAL CAUSE HAS BEEN ADDRESSED, THE INVESTIGATION COULD NOT CONCLUSIVELY DETERMINE THIS AS A DEFINITIVE ROOT CAUSE. 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 REPAIR, THREE (3) FAST-FIX 360 FAILED TO DEPLOY THE T2 IMPLANT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296133 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown