BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK ANCHOR ACCESSORIES

    MDR report key: 2251889 · Received September 16, 2011

    Report

    Report Number
    1221934-2011-00316
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 13, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. IN APPEARANCE, THE ANODIZE OF THE HANDLE IS BLOTCHY AND FADED; INDICATING EXTENSIVE USE OR THE POSSIBILITY THAT THE DEVICE HAS BEEN CLEANED IN AN ALKALINE SOLUTION. FUNCTIONALLY, THE ARTICULATION MECHANISM IS WORKING AS INTENDED. ATTENTION TO THE WORKING END OF THE DEVICE, THE DISTAL TIP, REVEALED THAT THE TOP PORTION OF THE JAW, THE ARTICULATING PORTION, IS MISSING; BROKEN AWAY. WHEN VIEWED UNDER POWER, WE CAN SEE THAT THE BREAK AREA IS RAGGED, TWISTED AND MAL FORMED, WHICH INDICATES THAT EXCESSIVE MECHANICAL FORCE HAS BEEN APPLIED. THE DEVICE IS DESIGNED, MANUFACTURED AND MARKETED AS A SOFT TISSUE PENETRATING GRASPER/GRABBER FOR SUTURE RETRIEVAL, NOTHING MORE. IN THIS PARTICULAR ISSUE, THE DEVICE WAS USED INAPPROPRIATELY EITHER IN A VICE LIKE OR PRY BAR MANNER IN AN ATTEMPT TO EXTRACT HARD MATERIAL STUCK IN HARD BONE. WE CAN ONLY ATTRIBUTE THE DEVICE'S CONDITION TO TECHNIQUE, A USER ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE HEALIX BR ANCHOR THAT THE SURGEON WAS USING TO FIXATE BROKE WHILE IT WAS BEING DEPLOYED INTO THE BONE HOLE. THERE WERE APPROXIMATELY 3 TREADS OF THE ANCHOR SITTING PROUD TO THE BONE; IN AN ATTEMPT AT REMOVING THE SCREW FRAGMENT FROM THE BONE HOLE, THE SURGEON USED A MITEK GRASPER GRABBER TO GRAB AND EXTRICATE THE FRAGMENT; HOWEVER THE TIP OF THE "GRABBER" BROKE OFF AND FELL INTO THE PATIENT'S JOINT SPACE. THE BROKEN INSTRUMENT FRAGMENT WAS EASILY RETRIEVED FROM THE BODY; THE SURGEON USED OTHER MEANS TO RETRIEVE THE BONE ANCHOR, AND THEN USED ANOTHER SAME TYPE FIXATION DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK ANCHOR ACCESSORIES MITEK GRASPER GRABBER NBH DEPUY MITEK NA 09D1

    Patients

    Seq Age Sex Outcome Treatment
    1