BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 20187066 · Received September 11, 2024

    Report

    Report Number
    1219602-2024-01973
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 14, 2024
    Report Date
    November 29, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). D4, LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2145949 AND 2150409. HOWEVER, IT IS UNKNOWN WHICH OF THE TWO HAD THE REPORTABLE MALFUNCTION. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE TWO LOTS REPORTED: 20-FEB-2027 (2145949) AND 26-MAR-2027 (2150409). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE TWO LOTS REPORTED: 20-FEB-2024 (2145949) AND 26-MAR-2024 (2150409). 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 INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    H6, TYPE OF INVESTIGATION CODES WERE UPDATED. RESULTS OF INVESTIGATION: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION ALONG WITH 3 MORE DEVICES. A VISUAL INSPECTION REVEALED THEY ARE NOT IN THEIR ORIGINAL PACKAGING. THE INSERTION DEVICES WERE RETURNED PRET2/POSTT1 SETTING WITH NO SUTURE OR IMPLANTS RETURNED. THERE IS BIOLOGICAL DEBRIS ON THE DEVICES. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THEY CYCLE AS DESIGNED. 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. 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 SURGERY, TWO (2) FAST-FIX COULD NOT TRIGGER T2 DESPITE CAREFUL APPLICATION AND SLOW RETRACTION WITH SLIGHT OSCILLATING MOVEMENTS, THE SLIP KNOT COULD NOT BE PULLED AS USUAL, IT WAS VERY DIFFICULT. NOTHING REMAINED IN THE JOINT. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021290 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