BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 6411449 · Received March 16, 2017

    Report

    Report Number
    3005985723-2017-00125
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    March 13, 2017
    Report Date
    July 24, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE RETURNED DEVICE WAS CONFIRMED TO BE A 3.0 RIO® ROBOTIC ARM - MICS, CATALOG # 209999, SERIAL# (B)(4) THAT HAD CONNECTION ERRORS. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT 209999, SERIAL# (B)(4) WAS BUILT AND PASSED ALL QIPS AS EVIDENCED BY THE QUALITY REVIEW AND SIGNATURE WHICH WAS COMPLETED ON JANAURY 6, 2017. DEVICE EVALUATION AND RESULTS: FROM THE INFORMATION PROVIDED THE 502 ERROR WHICH IS A COMMUNICATION ERROR WAS NOT ABLE TO BE DETECTED, HOWEVER, A SUBSEQUENT CONNECTION ERROR WAS OBSERVED IN THE SYSTEM REPORT. FROM THE ATTACHED EMAILS THE FAILURE WAS NARROWED DOWN TO AN ETHERNET CAT5 TO FIBER CONVERTER, CATALOG# 200933 . THE ITEMS WAS REPLACED AND THE SYSTEM RETURNED TO FULL FUNCTION. AS A RESULT OF A SIMILAR INCIDENT THE SYSTEM WAS RETURNED TO STRYKER AND PER GSP CASE# 149190 THE CONNECTION ERRORS WERE CONFIRMED. THE CPCI WAS REPLACED AND SUBSEQUENT TESTING DECLARED THE SYSTEM READY FOR CLINICAL USE. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 209999, SERIAL NUMBER (B)(4) AND P/N 200933 ETHERNET CAT5 TO FIBER CONVERTER SHOWS THREE ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE PR# 1488459, 1515423, 1515424. CONCLUSIONS: THE FAILURE MODE OF A .0 RIO® ROBOTIC ARM - MICS WITH CONNECTION ERRORS WAS CONFIRMED. THE ISSUE OCCURRED DURING A CASE AND RESULTED IN ITS CANCELLATION. THE FAILURE WAS NARROWED DOWN TO A FAULTY CAT5 TO ETHERNET CONVERTER WHICH WAS REPLACED DURING THE SERVICE VISIT. CORRECTIVE ACTION/PREVENTIVE ACTION: NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE MAKO SYSTEM ENCOUNTERED AN ERROR 502 DURING A PROCEDURE. TROUBLE SHOOTING WAS CARRIED OUT AND ENGINEERING CONTACTED FOR SUPPORT DURING THE PROCEDURE. THE ERROR WAS NOT ABLE TO BE RESOLVED THEREFORE THE CASE WAS ABORTED. THE PATIENT HAD AN INCISION MADE AND BONE PINS PLACED IN THE TIBIA AND FEMUR. OSTEOPHYTES WERE ALSO REMOVED. THE PATIENT'S WOUNDS WERE CLOSED WITHOUT BEGINNING TO BURR BONE. THE PROCEDURE WAS NOT COMPLETED AND WILL BE RESCHEDULED FOR A LATER DATE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE MAKO SYSTEM ENCOUNTERED AN ERROR 502 DURING A PROCEDURE. TROUBLE SHOOTING WAS CARRIED OUT AND ENGINEERING CONTACTED FOR SUPPORT DURING THE PROCEDURE. THE ERROR WAS NOT ABLE TO BE RESOLVED THEREFORE THE CASE WAS ABORTED. THE PATIENT HAD AN INCISION MADE AND BONE PINS PLACED IN THE TIBIA AND FEMUR. OSTEOPHYTES WERE ALSO REMOVED. THE PATIENT'S WOUNDS WERE CLOSED WITHOUT BEGINNING TO BURR BONE. THE PROCEDURE WAS NOT COMPLETED AND WILL BE RESCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192251 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other