BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7229098 · Received January 30, 2018

    Report

    Report Number
    3005985723-2018-00047
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Date of Event
    January 24, 2018
    Report Date
    April 11, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT THE HANDPIECE DID NOT WORK. PRODUCT HISTORY REVIEW DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0AJX AND 24 DEVICES INCLUDING 4203154 WERE ACCEPTED INTO FINAL STOCK ON (B)(6) 2017. A REVIEW OF QT17-12-0027 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K0AJX, P/N (B)(6) SHOWS NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. DIMENSIONAL INSPECTION DIMENSIONAL INSPECTION WAS NOT COMPLETED. REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL. SCREENSHOT OF PASSING TEST IS ATTACHED. CONCLUSION FAILURE WAS NOT DUPLICATED. THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL. NC/CAPA HISTORY REVIEW A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC 1414517 AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    DR BARZIDEH AND I WERE STARTING OUR FIRST ROBOTIC TKA OF 2 CASES FOR THE DAY WHEN OUR HANDPIECES WERE MALFUNCTIONING. THE FIRST HANDPIECE WAS ABLE TO PASS A MICS STATUS CHECK. AT THE BEGINNING OF THE CASE AS WE WENT INTO PROCEDURE, THE ROBOT ACTED NORMALLY THROUGH RIO SETUP AND RIO REGISTRATION. AS WE COMPLETED BONE REGISTRATION AND WENT INTO BONE CUTS. THE HANDPIECE WOULD ENTER THE HAPTIC BOUNDARY BUT WAS UNRESPONSIVE AS WE TRIED TO CUT BONE. WARNING WAS FAULT_VBUS_LOW. IMMEDIATELY TALKED WITH FIELD SERVICE AND WAS ADVISED THAT HANDPIECES WERE FAILING. TRIED MULTIPLE ATTEMPTS TO SALVAGE THE CASE WITH NO RESOLVE. SURGICAL DELAY OF 10 MINUTES BEFORE WE WENT TO MANUAL PROCEDURE. ALSO WILL BE CANCELING OUR SECOND CASE AS THE PATIENT FOR SECOND CASE IS ADMENT ON RECIEVING A ROBOTIC MAKO TKA.

    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

    DR (B)(6) AND I WERE STARTING OUR FIRST ROBOTIC TKA OF 2 CASES FOR THE DAY WHEN OUR HANDPIECES WERE MALFUNCTIONING. THE FIRST HANDPIECE WAS ABLE TO PASS A MICS STATUS CHECK. AT THE BEGINNING OF THE CASE AS WE WENT INTO PROCEDURE, THE ROBOT ACTED NORMALLY THROUGH RIO SETUP AND RIO REGISTRATION. AS WE COMPLETED BONE REGISTRATION AND WENT INTO BONE CUTS. THE HANDPIECE WOULD ENTER THE HAPTIC BOUNDARY BUT WAS UNRESPONSIVE AS WE TRIED TO CUT BONE. WARNING WAS FAULT_VBUS_LOW. IMMEDIATELY TALKED WITH FIELD SERVICE AND WAS ADVISED THAT HANDPIECES WERE FAILING. TRIED MULTIPLE ATTEMPTS TO SALVAGE THE CASE WITH NO RESOLVE. SURGICAL DELAY OF 10 MINUTES BEFORE WE WENT TO MANUAL PROCEDURE. ALSO WILL BE CANCELING OUR SECOND CASE AS THE PATIENT FOR SECOND CASE IS ADMENT ON RECEIVING A ROBOTIC MAKO TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72032 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4203154 / 42031117

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization