BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM

    MDR report key: 4760145 · Received May 8, 2015

    Report

    Report Number
    3005985723-2015-00070
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 18, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A J5 TOP ASSEMBLY, P/N 200422, LOT ROB056. DEVICE EVALUATION AND RESULTS: ACCORDING TO GSP CASE (B)(4), THE J5 MOTOR RETURNED FROM THE FIELD WITH HALL ERRORS. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 1 ROBOT ARM THAT INCLUDED THE REPORTED J5 TOP ASSEMBLY WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 05/06/2009. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 200422 ON ROB056 SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 200422 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #767. CONCLUSIONS: THE FAILURE WAS CONFIRMED DURING THE INSPECTION.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. A MAKO FIELD SERVICE ENGINEER CONDUCTED ON-SITE TESTING OF THE RIO AND WAS ABLE TO CONFIRM THE ALLEGED FAILURE OF THE ROBOTIC ARM. THE ISSUE WAS RESOLVED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS OBTAINED IN THE FUTURE.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. TOWARDS THE END OF THE CASE, THE RIO ARM EXPERIENCED JOINT MOTOR ERRORS. THE RESULTING OUTCOME OF THE CASE WAS SUCCESSFUL AND THERE WAS NO HARM TO PATIENT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. TOWARDS THE END OF THE CASE, THE RIO ARM EXPERIENCED JOINT MOTOR ERRORS. THE RESULTING OUTCOME OF THE CASE WAS SUCCESSFUL AND THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304416 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM STEROTAXIC DEVICE OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention