BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 21069154 · Received January 3, 2025

    Report

    Report Number
    3006524618-2025-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 24, 2025
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    UDI-DI
    00885556724644
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (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: INTERNAL COMPLAINT REFERENCE NUMBER:(B)(4). H2: ADDITIONAL INFORMATION ON: B5 & H6 (MEDICAL DEVICE PROBLEM CODE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE 2.8 MM Q-FIX ANCHOR HAD AN UNSPECIFIED FAILURE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE 2.8 MM Q-FIX ANCHOR POINT WITH THE THREAD DID NOT COME OUT OF THE FEEDER. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640166 2.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2150117 00885556724644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown