BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 23364576 · Received October 23, 2025

    Report

    Report Number
    3006524618-2025-00607
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    UDI-DI
    00885556724644
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE 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 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

    H10, H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED TWO DEVICES WERE RETURNED TOGETHER IN A SINGLE BIO PACKAGING. THERE WAS NO LOT DISCERNMENT INCLUDED. THE ANCHOR OF BOTH DEVICES ARE STILL IN THE INSERTION TUBES. BIO DEBRIS IS INSIDE THE TUBES AND ON THE ANCHORS. THE SUTURES OF BOTH DEVICES STILL RUN THROUGH THE CANNULA TO THE CLEAT. BOTH THE CLEATS ARE FULLY EXTENDED. A FUNCTIONAL EVALUATION SHOWED BOTH THE DRIVERS CAN NO LONGER BE USED TO ADVANCE THE ANCHORS AS THE SPOOL CLEATS ARE FULLY EXTENDED FROM THE BODY OF THE HANDLES AND THE RATCHETS ARE LOCKED. 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. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE PROCEDURAL VARIANCE, OR DEVIATIONS FROM ESTABLISHED PROTOCOLS, INCREASING RISKS AND LEADING TO UNINTENDED CONSEQUENCES ((1) EXCESSIVE FORCE (2) MISALIGNMENT OF INSERTER AND IMPLANT DURING AND AFTER INSERTION (3) NOT USING DRILL GUIDE WHEN DEPLOYING 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 A SHOULDER ARTHROSCOPY, THE SUTURES OF THE 2.8 MM Q-FIX ANCHORS DID NOT PULL THROUGH THE DEVICE AND WERE LOCKED IN PLACE. THE ANCHOR AND SUTURE WAS CUT OUT OF THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY IN WHICH THE PATIENT DID NOT UNDERGO ADDITIONAL ANESTHESIA, PLACING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONALLY DRILLED BONE HOLE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729511 2.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2162207 00885556724644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown