BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J6 ARM FOR HIP WITH QD

    MDR report key: 5185565 · Received October 28, 2015

    Report

    Report Number
    3005985723-2015-00221
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    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 J6 ARM FOR HIP WITH QD, CATALOG: 203477, RMA #: (B)(4). DEVICE EVALUATION AND RESULTS: PER GSP#(B)(4), THE J6 KEEPS REGISTERING ENCODER ERRORS: DURING THE INVESTIGATION OF THE REPORTED ISSUE ON THE 203477-R J6 ARM THE ENCODER COVER WAS REMOVED AND THE 203486 ENCODER GLASS WAS THOROUGHLY INSPECTED FOR ANY SIGNS OF DAMAGE OR DEBRIS. NO DAMAGE OR DEBRIS WAS FOUND DURING THE INVESTIGATION. THE 203486 ENCODER GLASS WAS CLEANED WITH BOTH CANNED AIR AND ALCOHOL WIPES. AFTER CLEANING THE 203486 ENCODER GLASS THE 201386 ENCODER READ HEAD WAS NOT SEEING THE 203486 ENCODER GLASS IN ITS OPTIMAL RANGE. THE 201386 ENCODER READ HEAD'S VALUES WERE CHANGING WHEN MANIPULATING THE CABLE. IT WAS DETERMINED TO REPLACE THE 201386 ENCODER READ HEAD. ONE NEW 207169 ENCODER READ HEAD WAS INSTALLED ON THE 203477-R J6 ARM. AFTER SETTING THE 207169 ENCODER READ HEAD TO IT'S OPTIMAL VALUE THE 203477-R J6 ARM WAS RUN THROUGH THE QIP 0216 JOINT LEVEL TEST WITH PASSING RESULTS. ALL REMOVAL, INSTALLATION AND TESTING STEPS WERE PERFORMED FOLLOWING THE AI 203477 J6 ARM, THE 204499 RIO SERVICE MANUAL AND THE QIP 0216 JOINT LEVEL TEST. THE PASSING GREEN SCREEN SHOT AND THE INSPECTION RECORD ARE ATTACHED TO THE WORK ORDER. DEVICE HISTORY REVIEW: NOT PERFORMED AS THE 201386 ENCODER READ HEAD IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 203477 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 203477 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #860. CONCLUSIONS: THE FAILURE WAS CONFIRMED BY THE FSE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    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 PERFORMED A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE RIO ARM EXPERIENCED JOINT ANGLE INCONSISTENCY 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 TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE RIO ARM EXPERIENCED JOINT ANGLE INCONSISTENCY 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
    716428 J6 ARM FOR HIP WITH QD STEREOTACTIC DEVICE, ACCESSROY OLO MAKO SURGICAL CORP. LOT #162477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention