BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-FIX KNTLS ASA 1.8MM W/1 UB SUT BL

    MDR report key: 23271299 · Received October 10, 2025

    Report

    Report Number
    1219602-2025-02543
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 11, 2025
    Report Date
    November 14, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    00885556901687
    PMA / PMN Number
    K241435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H11 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. **TWO DEVICES LOT: 2173625/2178008 WERE USED WERE IT LEAD TO THE ADDITIONAL BONE HOLE, BOTH OF THEM WILL BE INCLUDED IN 1 REPORT SINCE ITS UNKNOWN WHICH DEVICE CAUSED THE ADDITIONAL BONE HOLE TO BE REQUIRED.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. HOWEVER, AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGE FOUND A DEPLOYED Q-FIX DEVICE. THE ANCHOR SEEMS CYLINDRICAL. 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. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE A FAILURE TO FULLY ACTUATE THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT TWO (2) UNITS OF THE Q-FIX KNTLS ASA 1.8MM W/1 UB SUT BL (B)(4) LOT: 2173625 & (B)(4) LOT: 2178008) DIDN¿T BALL UP AGAINST THE INSERTER AND APPEARED TO BE CYLINDRICAL. IT TOOK AN ADDITIONAL MINUTE OR TWO AND HAD TO SLIGHTLY ALTER ANCHOR LOCATION WITH A SMALL DEFECT LEFT BEHIND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343253 Q-FIX KNTLS ASA 1.8MM W/1 UB SUT BL FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 2173625 00885556901687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 72205882