BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 3223861 · Received July 2, 2013

    Report

    Report Number
    3005985723-2013-00044
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT WAS COMPLETED BY MAKO SURGICAL. THE ROOT CAUSE OF THE EVENT IS INCONCLUSIVE. THE INITIAL STEREOTACTIC ENTRY ISSUE IS MOST LIKELY A SHIFTED ARRAY; HOWEVER, THERE IS NO DATA TO SUPPORT THIS CONCLUSION AS THERE IS NO RECORDED CHECKPOINT CHECK FAILURE. IT IS SUSPECTED A REGISTRATION SHIFT OCCURRED WHEN THE SURGEON ATTEMPTED TO REGISTER THE ALREADY-RESECTED TIBIA AND THE REGISTRATION RESULTED IN POOR RESULTS AS WELL AS A FAILING VERIFICATION SPHERE. A SHIFTED REGISTRATION WOULD SHIFT THE IMPLANT PLAN LOCATION AND LEAD THE RIO TO BELIEVE THE BURR'S CENTER POINT IS AT A DIFFERENT LOCATION (VIRTUALLY) THAN COMPARED TO THE REAL LOCATION.

    Description of Event or Problem · 1

    THE SURGEON WAS PREPARING TO PERFORM A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). WHILE THE SURGEON WAS BURRING THE TIBIA, HE PAUSED TO REPOSITION THE LEG. WHEN THE SURGEON ATTEMPTED TO APPROACH THE TIBIA AGAIN, HE WAS UNABLE TO ACTIVATE BURR MODE IN THE STEREOTACTIC ZONE. VARIOUS ATTEMPTS AT TROUBLESHOOTING WERE UNSUCCESSFUL, AND IT WAS SUSPECTED THAT THE TIBIAL ARRAY HAD SHIFTED. THE SURGEON COMPLETED THE TIBIAL RESECTION WITH A MANUAL SAW BLADE, AND REPORTED A SUCCESSFUL CASE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301499 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 201000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS