BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-LOK

    MDR report key: 2160782 · Received July 5, 2011

    Report

    Report Number
    8043971-2011-00008
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    April 28, 2011
    Report Date
    July 5, 2011
    Manufacturer
    T.A.G. MEDICAL PRODUCTS, CORP. LTD.
    Product Code
    MBI
    PMA / PMN Number
    K101616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS WAS BELIEVED TO BE A RARE EVENT, THE MANUFACTURER HAS CONDUCTED A PROACTIVE INVESTIGATION. A COMPLETE REVIEW OF THE DHRS HAS OCCURRED AND CONFIRMED THAT THE DEVICES WERE MANUFACTURED ACCORDING TO THEIR REQUIREMENTS. ALL OPERATORS HAVE BEEN MADE AWARE OF THE ISSUES AND THEIR ROLE IN PREVENTING SUCH A NON-CONFORMANCE. IN ADDITION, TWO LEVELS OF 100% INSPECTION HAVE BEEN IMPLEMENTED TO FURTHER DETECT AND PREVENT SUCH AN EVENT FROM RE-OCCURRING. LASTLY, A REVIEW OF WORK-IN-PROGRESS AND INVENTORY HAS BEEN CONDUCTED. THE RESULTS CONFIRM THIS TO BE AN ISOLATED OCCURRENCE RATHER THAN A WIDESPREAD SYSTEMIC PROBLEM. BASED UPON THE RISK ANALYSIS AND DATA, WE BELIEVE POTENTIAL NONCONFORMING RATE TO BE (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR, AN ACL KNEE PROCEDURE WAS BEING PERFORMED ON A PATIENT WITH A 15MM G-LOK. THIS G-LOK, WHICH WAS LOADED INTO XL BUTTON AND GRAFT, WAS BEING PASSED THROUGH A 9.5MM TUNNEL IN THE KNEE WITH A VERSITOMIC FLEXIBLE PIN. AFTER THE DEVICE HAD BEEN POSITIONED IN THE PATIENT, THE SURGEON PULLED IT HARD, AND THE LOOP BROKE. THE GRAFT WAS RECOVERED, AS WAS THE BUTTON AND G-LOK LOOP. THE SAME BUTTON WAS LOADED ONTO A REPLACEMENT 15MM G-LOK LOOP. THE TUNNEL WAS WIDENED USING A 10MM VERSITOMIC REAMER. THE FLEXIBLE PIN WAS RE-INSERTED INTO THE FEMORAL TUNNEL. THE REPLACEMENT G-LOK WAS DEPLOYED SUCCESSFULLY. TOTAL DELAY WAS 15 MINUTES, AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED. IT WAS CONFIRMED THAT NO ADDITIONAL ANESTHESIA WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-LOK MULTIPLE COMPONENT BONE FIXATION DEVICE MBI T.A.G. MEDICAL PRODUCTS, CORP. LTD. 10R11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention