BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 20412258 · Received October 9, 2024

    Report

    Report Number
    3006524618-2024-00437
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    UDI-DI
    00885556724644
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H10 B5, D4 AND H4: EVENT DESCRIPTION, LOT NUMBER, MFG AND EXP DATES UPDATED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). TWO LOT NUMBERS WERE PROVIDED(2143545/2143538) BUT SPECIFY THAT ONE OF THEM WAS THE ONE THAT WAS USED AND MALFUNCTIONED AND THE OTHER WAS ONLY ALREADY ON THE SURGERY TABLE AND WAS DECIDED NOT TO BE USED. SINCE IT IS UNKNOWN WHICH LOT NUMBER FAILED AND WHICH ONE WAS ONLY NOT USED, IT WILL BE LEFT AS LOT UNKNOWN WHILE IT IS CLARIFIED. H10 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE IMPLANT OF A 2.8MM Q-FIX GOT STUCK WHEN TRYING TO ADVANCE IT TOWARDS THE BONE, IT WAS DRILLED AGAIN BUT WHEN TRYING TO LOWER THE IMPLANT IT DID NOT GO THROUGH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A 5.5MM HEALICOIL PK ANCHOR. NO FURTHER COMPLICATIONS WERE REPORTED. THE BACKUP IMPLANT WAS USED IN THE HOLE INITIALLY DRILLED FOR THE Q-FIX, SO NO VOID WAS LEFT IN THE PATIENT. NO DAMAGE CAUSED, THE PATIENT'S HEALTH CONDITION IS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE IMPLANT OF A 2.8MM Q-FIX GOT STUCK WHEN TRYING TO ADVANCE IT TOWARDS THE BONE, IT WAS DRILLED AGAIN BUT WHEN TRYING TO LOWER THE IMPLANT IT DID NOT GO THROUGH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING TWO(2) 5.5MM HEALICOIL PK ANCHORS. NO FURTHER COMPLICATIONS WERE REPORTED. NO DAMAGE CAUSED, THE PATIENT'S HEALTH CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957175 2.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2143538 00885556724644

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male