BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 3970100 · Received April 29, 2014

    Report

    Report Number
    3005985723-2014-00050
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN PERFORMED AT MAKO SURGICAL. THE ROOT CAUSE OF THIS ISSUE IS ANSPACH CONTROLLER BOARD FAILURE. THE ANSPACH CONTROLLER BOARD FEEDS POWER FROM THE POWER SUPPLY TO THE ANSPACH MOTOR WHEN ITS INPUT IS ENABLED. THE EVALUATION CONCLUDED THAT THE ROOT CAUSE OF THIS PARTICULAR ISSUE IS THE ANSPACH CONTROL SOFTWARE REJECTING DISABLE SIGNALS DURING PERIODS OF HIGH ACTIVITY OR STRAIN, SUCH AS EXCESSIVE TORQUE TO THE MOTOR. WHEN THE DISABLE SIGNALS ARE REJECTED, THE ANSPACH MOTOR CONTINUES TO SPIN. THE ISSUE WAS COMMUNICATED WITH THE WORKAROUND TO THE SALES TEAM. DURING THE COMMUNICATION, THE SALES TEAM WAS PROVIDED WITH THE PROPER TROUBLESHOOTING TECHNIQUE SHOULD THE ISSUE RECUR, AND HOW TO SAFELY STOP THE BURR FROM SPINNING. A PERMANENT DESIGN SOLUTION IS IN PROGRESS. TO DATE, NO SERIOUS INJURIES HAVE BEEN ASSOCIATED WITH THIS TYPE OF EVENT. THIS IS THE FIFTH REPORT OF THIS TYPE OF EVENT IN OVER (B)(4) CASES SINCE 2013.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE (MCK) PROSTHESIS. DURING TIBIAL BURRING, THE BURR MOTOR STALLED AND AN ERROR MESSAGE APPEARED ON THE RIO. THE RESET FOUNDATION WAS SELECTED AND THE ARM WAS MOVED ABOUT 12 INCHES AWAY FROM THE KNEE. THE SURGEON NOTICED THAT HE BURR WAS STILL SPINNING WITHOUT THE HAND TRIGGER PRESSED. THE MOTOR WAS UNPLUGGED, AND THE BURR SLOWLY STOPPED SPINNING. THE MOTOR WAS THEN REMOVED AND RESEATED. THE SURGEON PROCEEDED WITH THE CASE, AND USED THE RIO TO RESECT THE POST HOLES. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255505 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTAXIC DEVICE OLO MAKO SURGICAL CORP. 204000

    Patients

    Seq Age Sex Outcome Treatment
    1 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) PROSTHESIS