BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7654777 · Received July 2, 2018

    Report

    Report Number
    3005985723-2018-00392
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 4, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE MICS WAS NON FUNCTIONAL DURING A TKA CASE. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. (B)(4) HAS BEEN INITIATED IN REGARDS TO MISSING PRODUCT. PRODUCT HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K082X AND (B)(4) WERE ACCEPTED INTO FINAL STOCK ON 12/12/2016. A REVIEW OF QT16-12-0040 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, L/N 42040716 SHOWS 02 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE (B)(4). CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS (B)(4) AND CAPA (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    MICS HANDPIECE WAS UNRESPONSIVE AND FAILED MICS STATUS CHECK. SURGEON COMPLETED BALANCING, WHEN WE BROUGHT THE ROBOT IN TO MAKE CUTS, THE SURGEON PULLED THE TRIGGER TO AUTO ALIGN MICS, THERE WAS NO RESPONSE. WE PERFORMED TROUBLESHOOTING STEPS, TO INCLUDE RESETTING THE CUTTER, STILL NO RESPONSE FROM THE MICS. WE SWAPPED THE MICS FOR A NEW ONE; PERFORMED A MICS STATUS CHECK - MICS FAILED. WE PERFORMED ADDITIONAL TROUBLESHOOTING AND ATTEMPTED THE STATUS CHECK AGAIN, STILL FAILED. WE SWAPPED THE MICS OUT AGAIN, THIS TIME THE MICS PASSED CHECKS AND WORKED PROPERLY. TKA CASE DELAYED 5 MINUTES. AFTER THE SURGERY WAS COMPLETED; I PERFORMED A MICS STATUS CHECKS ON ALL SIX MICS HANDPIECES - FOUR FAILED (INCLUDING THE TWO USED IN THE SURGERY).

    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

    MICS HANDPIECE WAS UNRESPONSIVE AND FAILED MICS STATUS CHECK. SURGEON COMPLETED BALANCING, WHEN WE BROUGHT THE ROBOT IN TO MAKE CUTS, THE SURGEON PULLED THE TRIGGER TO AUTO ALIGN MICS, THERE WAS NO RESPONSE. WE PERFORMED TROUBLESHOOTING STEPS, TO INCLUDE RESETTING THE CUTTER, STILL NO RESPONSE FROM THE MICS. WE SWAPPED THE MICS FOR A NEW ONE; PERFORMED A MICS STATUS CHECK - MICS FAILED. WE PERFORMED ADDITIONAL TROUBLESHOOTING AND ATTEMPTED THE STATUS CHECK AGAIN, STILL FAILED. WE SWAPPED THE MICS OUT AGAIN, THIS TIME THE MICS PASSED CHECKS AND WORKED PROPERLY. TKA CASE DELAYED 5 MINUTES. AFTER THE SURGERY WAS COMPLETED; I PERFORMED A MICS STATUS CHECKS ON ALL SIX MICS HANDPIECES - FOUR FAILED (INCLUDING THE TWO USED IN THE SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496444 HANDPIECE MICS STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP. 3200949 / 42040716 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization