BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM

    MDR report key: 5639141 · Received May 6, 2016

    Report

    Report Number
    3005985723-2016-00142
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 18, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING A FAILED REAMER VERIFICATION CHECKPOINT INVOLVING 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM, CATALOG: 204000 WAS REPORTED. METHOD AND RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 86 FOUND THE PT REVIEW SUCCESSFULLY PASSED, ALL ASSOCIATED NPRS HAVE BEEN CLOSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 204000) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING HARDWARE #22 AND #20 ERRORS. THERE WERE NO OTHER REPORTED EVENTS FOR THE LISTED CATALOG NUMBER. CONCLUSION: PER GSP 130356, THE SYSTEM WAS DE-INSTALLED AND SHIPPED TO THE HOME OFFICE FOR FURTHER EVALUATION. PER GSP 130763, THE TECHNICIAN NOTED: "UPON RECEIPT, IT WAS OBSERVED THAT THE CPCI HAD BURNT COMPONENTS INSIDE AND MUST BE REPLACED. SUCCESSFULLY INSTALLED NEW 200980 CPCI WITH COMPUTER SWAP PER SERVICE MANUAL. FOLLOWING CPCI REPLACEMENT, A J4 JOINT ENCODER ERROR WAS PRESENT. WITH THE ASSISTANCE OF ENGINEERING, IT WAS DISCOVERED THAT J4 APPEARED TO BE OPERATING CORRECTLY BUT A POSSIBLE SPIKE IN VOLTAGE MUST HAVE DAMAGED THE JOINT ENCODER. SUCCESSFULLY REPLACED 207149 J4 JOINT ENCODER PER SERVICE MANUAL. SYSTEM APPEARED TO FUNCTION PROPERLY. SUCCESSFULLY COMPLETED ARM STATUS AND HOMING PER SERVICE MANUAL. COMBINED ACCURACY CHECK WAS UNSUCCESSFUL DUE TO THE NEW JOINT ENCODER. UNSUCCESSFULLY ATTEMPTED TO PERFORM MOTOR PHASING. DURING MOTOR PHASING PROCEDURE, J4 MADE AN ERRATIC NOISE THEN FAILED THE TEST. IMMEDIATELY FOLLOWING THE FAILURE, IT WAS OBSERVED THAT J4 MOVEMENT WAS NO LONGER SMOOTH AND A COGGING FEEL WAS PRESENT. IT IS BELIEVED THAT THE ORIGINAL CPCI FAILURE SENT A BAD SIGNAL TO THE J4 ARM MAKING IT VULNERABLE TO FAILURE. J4 WAS SUCCESSFULLY REMOVED AND A NEW 207564 J4 ARM WAS INSTALLED PER SERVICE MANUAL. IT IS NOW BELIEVED BY FACTORY SERVICE AND ENGINEERING THAT ALL OF THE ORIGINAL FAULTY COMPONENTS HAVE BEEN REMOVED AND DESIGNATED TO ENGINEERING TO INVESTIGATE. ROB086 IS SCHEDULED TO BE UPGRADED TO 3.0 PLATFORM THEREFORE ENGINEERING DEPARTMENT HAS AGREED THAT THE REPAIR WILL BE ADDRESSED DURING THE UPGRADE THROUGH INSTALLATION OF NEW INTERNAL COMPONENTS."

    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 PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE THE ROBOTIC UNIT ARM LOCKED UP DURING RIO REGISTRATION AND DISPLAYED ERRORS "HARDWARE #22" AND "HARDWARE #20". TECHNICAL SUPPORT WAS CONTACTED AND IDENTIFIED THE ERRORS AS RELATING TO A SHORT CIRCUIT IN THE INTERNAL WIRING OF THE ROBOT. MPS ON SITE RECOMMENDED TO THE SURGEON THAT THE ROBOTIC PORTION OF THE CASE SHOULD BE ABORTED. UPON ATTEMPTING TO MOVE THE ARM INTO THE HOME POSITION, SMOKE BEGAN TO VISIBLY POUR FROM THE BASE OF THE ROBOT. THE ROBOT WAS THEN UNPLUGGED AND REMOVED TO THE HALL. THE CASE HAD A 10 MINUTE DELAY BEFORE CONVERTED TO A TOTAL KNEE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE THE ROBOTIC UNIT ARM LOCKED UP DURING RIO REGISTRATION AND DISPLAYED ERRORS "HARDWARE #22" AND "HARDWARE #20". TECHNICAL SUPPORT WAS CONTACTED AND IDENTIFIED THE ERRORS AS RELATING TO A SHORT CIRCUIT IN THE INTERNAL WIRING OF THE ROBOT. MPS ON SITE RECOMMENDED TO THE SURGEON THAT THE ROBOTIC PORTION OF THE CASE SHOULD BE ABORTED. UPON ATTEMPTING TO MOVE THE ARM INTO THE HOME POSITION, SMOKE BEGAN TO VISIBLY POUR FROM THE BASE OF THE ROBOT. THE ROBOT WAS THEN UNPLUGGED AND REMOVED TO THE HALL. THE CASE HAD A 10 MINUTE DELAY BEFORE CONVERTED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292521 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM STEREOTACTIC DEVICE, ROBOTIC OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other