BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 16655253 · Received March 31, 2023

    Report

    Report Number
    3009185973-2023-00010
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 6, 2023
    Report Date
    October 12, 2023
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE ASSOCIATED SOFTWARE LOGS WERE PROVIDED TO THE POST MARKET SURVEILLANCE TEAM AND ANALYZED BY A SUBJECT MATTER EXPERT. BASED ON THE LOGS AND THE ELECTRODE MEASUREMENT ANALYSIS PERFORMED, THE REPORTED ELECTRODE PLACEMENT INACCURACY IS CONFIRMED. THE RE-DRILLED TRAJECTORY, ¿LEFT CMN¿, WAS >2MM OFF THE PLANNED ENTRY POINT. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS: THE USER PERFORMED MANUAL BONE FIDUCIAL REGISTRATION WITH THE POINTER AND ACHIEVED A PASSING RMS RESULT OF 0.50MM. THE REGISTRATION VERIFICATION WAS COMPLETED WITH MULTIPLE VALIDATION POINTS THAT EXCEEDED THE DEVICE¿S SPECIFICATION LIMIT OF 2MM. THE LOGS SHOW THE SOFTWARE NOTIFIED THE USER THAT ¿A SIGNIFICANT ERROR HAS BEEN DETECTED ON THIS POINT¿ FOR THE FOUR VERIFICATION POINTS THAT WERE ABOVE THE 2MM THRESHOLD. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IN THE ACCURACY VERIFICATION PROCEDURE OF THE USER MANUAL BRAIN APPLICATION, IT RECOMMENDS THAT IF TOO HIGH OF AN ERROR IS DETECTED ON A POINT DURING THE VERIFICATION PROCESS, THE USER SHOULD VISUALLY CHECK THE POINT AND REDO REGISTRATION, IF NECESSARY. IN THIS CASE, THE USER CHOSE TO VALIDATE THE HIGH ERRORS AND PROCEED WITH THE CASE, WHICH IS NOT ADVISED. IT SHOWS THAT THE REGISTRATION VERIFICATION ACCURACY WAS NOT OPTIMAL, WHICH CAN CONTRIBUTE TO ELECTRODE INACCURACY. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE TO ASSESS THE FUNCTIONALITY AND ACCURACY OF THE ROSA UNIT USED DURING THIS CASE. THE FSE PERFORMED A FULL PREVENTIVE MAINTENANCE AND ALL TESTS PASSED. THE UNIT WAS CONFIRMED TO BE IN WORKING ORDER. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER DRILLING THE SKULL ON THE FIRST TRAJECTORY ROBOT WAS TAKEN TO INTERMEDIATE THEN ROBOT WAS BROUGHT BACK TO THE FIRST TRAJECTORY AND SURGEON NOTICED THE TRAJECTORY WAS ABOUT 3 MM OFF. ROBOT WAS MADE TO GO ALL THE WAY HOME AND CAME BACK IN AND RE-CALIBRATED THE INSTRUMENT HOLDER AND TRAJECTORY WAS STILL OFF. DRILL BIT DID NOT LOOK BENT AND THE DRILL ADAPTOR WAS TOUCHING THE SKULL WHEN THE SURGEON DRILLED. SURGEON RE-DRILLED AND CONTINUED AS NORMAL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581106 ROSA ONE BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS N/A 3.1.6.90 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown