BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 3966450 · Received May 30, 2014

    Report

    Report Number
    3005985723-2014-00070
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN CONDUCTED AT MAKO SURGICAL. MAKO FIELD SERVICE ENGINEER (FSE) RESPONDED TO THE SITE THE SAME DAY TO CHECK AND TEST THE SYSTEM. THE ISSUE COULD NOT BE REPRODUCED, BUT A FULL PREVENTIVE MAINTENANCE PROCEDURE AND SOFTWARE RELOAD WAS PERFORMED AS PRECAUTIONARY MEASURES. THE RIO WAS RELEASED FOR CLINICAL USE, AND SUBSEQUENT PROCEDURES WERE PERFORMED SUCCESSFULLY WITH NO ISSUES OBSERVED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT SYSTEM. DURING TIBIAL RESECTION, THE SOFTWARE FROZE, AND THE ICON DEPICTING TRACKING OF THE TIBIAL ARRAY BEGAN FLICKERING. A SOFTWARE REBOOT FAILED TO RESOLVE THE ISSUE. ONLY A SMALL AREA OF THE TIBIA REMAINED TO BE RESECTED. THEREFORE, THE SURGEON DECIDED TO USE A FLAT OSTEOTOME TO REMOVE THE REMAINING BONE. THE MCK MANUAL INSTRUMENTATION SET WAS USED TO DRILL THE PEG HOLES. IN THE MEANTIME, THE RIO WAS REBOOTED, AND THE SURGEON WAS ABLE TO UTILIZE THE KINEMATIC BALANCING SOFTWARE FEATURE TO CONFIRM ACCURATE CASE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319778 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 201000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT SYS