BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7717795 · Received July 25, 2018

    Report

    Report Number
    3005985723-2018-00441
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 30, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE MICS WAS NOT WORKING DURING THE CASE LEADING TO THE SURGICAL DELAY OF 16-30 MINS. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. THE REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION REVEALED NO PHYSICAL DAMAGE AND THE PRODUCT FUNCTIONED AS INTENDED. THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST AND PASSED. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT NO K0BA1 AND 24 ACCEPTED INTO FINAL STOCK ON 06/08/ 2018. REVIEW OF QT18-06-0001 REVEALED THAT THE S/N (B)(4) WAS REJECTED DUE TO MOTOR NOT SPINNING. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER 42050518 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: ALLEGED FAILURE WAS NOT CONFIRMED. 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 NC1414517 AND CAPA 1450904.

    Description of Event or Problem · 0

    DURING BONE PREP, FOUR OF THE SIX CUTS WERE MADE SUCCESSFULLY. ON THE FIFTH CUT, WHICH WAS THE DISTAL FEMUR, WE FINISHED THE MEDIAL SIDE AND AS WE WENT TO CUT THE LATERAL SIDE, THE MICS LOST POWER. AN ERROR MESSAGE CAME UP WITH THE MESSAGE "FAULT VBUS LOW." THE COMPUTER SUGGESTED RESETTING THE CUTTER, WHICH WE DID. IT SUGGESTED UNPLUGGING THE MICS AND PLUGGING IT BACK IN, WHICH WE DID. WHEN FOLLOWING THESE STEPS, THE ERROR MESSAGE WOULD DISAPPEAR, THEN REAPPEAR A FEW SECONDS LATER. WE FINALLY SHUT THE ROBOT DOWN, RESTARTED IT, HOMED IT, AND ATTEMPTED A MICS STATUS CHECK. THE MICS PRODUCED NO POWER AND GAVE THE LOW BUS VOLTAGE FAULT ERROR AGAIN. WE THEN SHUT THE ROBOT DOWN TWO MORE TIMES, REPLACING THE MICS EACH TIME. WE ATTEMPTED THREE DIFFERENT MICS THAT ALL FAILED BEFORE THE SURGEON DECIDED TO PROCEED MANUALLY TO FINISH THE CASE. AT NO TIME WAS A BURR OVERRIDE ATTEMPTED. AS DR. (B)(6) FINISHED THE CASE MANUALLY, I THEN SHUT THE ROBOT DOWN TWO MORE TIMES AND ATTEMPTED A MICS STATUS CHECK ON EACH OF THE THREE MICS. ALL THREE PASSED AT THIS POINT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS DR. (B)(6) FINISHED THE CASE MANUALLY AND UTILIZED THE ROBOT TO CHECK LIGAMENT BALANCING AT THE END OF THE CASE. MICS - 42070617 / 4202483. THIS WAS THE SECOND MICS THAT WE ATTEMPTED TO USE IN DR. (B)(6) TKA WHERE THE MICS LOST POWER. WE HAD SHUT THE ROBOT DOWN, RESTARTED IT, HOMED IT, AND ATTACHED THIS MICS TO THE ROBOT. WE ATTEMPTED A MICS STATUS CHECK, AND THE MICS PRODUCED NO POWER. IT GAVE A LOW BUS VOLTAGE FAULT ERROR. MICS - 42050518 / 4204116. THIS WAS THE THIRD MICS THAT WE ATTEMPTED TO USE TO COMPLETE DR. (B)(6) ROBOTIC TKA. AFTER THE FIRST TWO MICS HAD FAILED TO WORK, WE SHUT DOWN THE ROBOT AGAIN, RESTARTED IT, HOMED IT, AND ATTACHED THE MICS. WE PERFORMED A MICS STATUS CHECK AND THE MICS PRODUCED NO POWER AND GAVE US THE ERROR MESSAGE "LOW BUS VOLTAGE FAULT." MICS - 42060717 / 4202641. CASE TYPE: TKA. WAS THERE A SURGICAL DELAY? YES -16-30 MINUTES.

    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

    DURING BONE PREP, FOUR OF THE SIX CUTS WERE MADE SUCCESSFULLY. ON THE FIFTH CUT, WHICH WAS THE DISTAL FEMUR, WE FINISHED THE MEDIAL SIDE AND AS WE WENT TO CUT THE LATERAL SIDE, THE MICS LOST POWER. AN ERROR MESSAGE CAME UP WITH THE MESSAGE "FAULT VBUS LOW." THE COMPUTER SUGGESTED RESETTING THE CUTTER, WHICH WE DID. IT SUGGESTED UNPLUGGING THE MICS AND PLUGGING IT BACK IN, WHICH WE DID. WHEN FOLLOWING THESE STEPS, THE ERROR MESSAGE WOULD DISAPPEAR, THEN REAPPEAR A FEW SECONDS LATER. WE FINALLY SHUT THE ROBOT DOWN, RESTARTED IT, HOMED IT, AND ATTEMPTED A MICS STATUS CHECK. THE MICS PRODUCED NO POWER AND GAVE THE LOW BUS VOLTAGE FAULT ERROR AGAIN. WE THEN SHUT THE ROBOT DOWN TWO MORE TIMES, REPLACING THE MICS EACH TIME. WE ATTEMPTED THREE DIFFERENT MICS THAT ALL FAILED BEFORE THE SURGEON DECIDED TO PROCEED MANUALLY TO FINISH THE CASE. AT NO TIME WAS A BURR OVERRIDE ATTEMPTED. AS DR. (B)(6) FINISHED THE CASE MANUALLY, I THEN SHUT THE ROBOT DOWN TWO MORE TIMES AND ATTEMPTED A MICS STATUS CHECK ON EACH OF THE THREE MICS. ALL THREE PASSED AT THIS POINT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS DR. (B)(6) FINISHED THE CASE MANUALLY AND UTILIZED THE ROBOT TO CHECK LIGAMENT BALANCING AT THE END OF THE CASE. MICS - 42070617 / 4202483. THIS WAS THE SECOND MICS THAT WE ATTEMPTED TO USE IN DR. (B)(6) TKA WHERE THE MICS LOST POWER. WE HAD SHUT THE ROBOT DOWN, RESTARTED IT, HOMED IT, AND ATTACHED THIS MICS TO THE ROBOT. WE ATTEMPTED A MICS STATUS CHECK, AND THE MICS PRODUCED NO POWER. IT GAVE A LOW BUS VOLTAGE FAULT ERROR. MICS - 42050518 / 4204116. THIS WAS THE THIRD MICS THAT WE ATTEMPTED TO USE TO COMPLETE DR. (B)(6)ROBOTIC TKA. AFTER THE FIRST TWO MICS HAD FAILED TO WORK, WE SHUT DOWN THE ROBOT AGAIN, RESTARTED IT, HOMED IT, AND ATTACHED THE MICS. WE PERFORMED A MICS STATUS CHECK AND THE MICS PRODUCED NO POWER AND GAVE US THE ERROR MESSAGE "LOW BUS VOLTAGE FAULT." MICS - 42060717 / 4202641 CASE TYPE: TKA. WAS THERE A SURGICAL DELAY? YES - 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561522 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42050518 4204116 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization