BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 16877045 · Received May 5, 2023

    Report

    Report Number
    3009185973-2023-00013
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    February 15, 2023
    Report Date
    May 5, 2023
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244030948
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE ASSOCIATED SYSTEM LOG FILES WERE PROVIDED AND REVIEWED BY A SUBJECT MATTER EXPERT. THE LOGS CONFIRM THE REPORTED EVENT AND PERMIT TO CONCLUDE THAT THE BONE FIDUCIAL ON WHICH THE CHECKS WERE DONE MOVED BETWEEN THE 1ST AND 2ND REGISTRATIONS AND BETWEEN THE 2ND AND 3RD REGISTRATIONS. ALSO, WITHIN THE 2ND REGISTRATION THE ROBOT WAS SENT TWICE ON A CONTROL FIDUCIAL. BOTH TIMES THE ROBOT WAS SENT EXACTLY TO THE SAME POSITION IN THE ROBOT REFERENTIAL, BUT THE 2 POSITIONS WERE DIFFERENT IN THE PATIENT REFERENTIAL. THIS POINTS TOWARDS THE REPORTED EVENTS BEING CAUSED BY SEVERAL PATIENT HEAD SHIFTS WITH A POTENTIAL HARDWARE ISSUE WITH THE HEADFRAME; HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED WITH THE INFORMATION AVAILABLE. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH CAUSED OR CONTRIBUTED TO THE OBSERVED INACCURACY. DEVICE HISTORY RECORDS WERE NOT REVIEWED AS REVIEW IS NOT REQUIRED FOR MEDICAL DEVICE SOFTWARE RELATED COMPLAINTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY WHILE USING A ROSA, REGISTRATION AND VERIFICATION WERE SUCCESSFUL. AFTER THE FIRST DBS LEAD WAS PLACED, AN INTRAOPERATIVE IMAGE WAS TAKEN VIA O-ARM. AFTER MERGING THE IMAGES, THE LEAD WAS NOTED TO BE OVER 3MM OFF FROM THE TARGET. SURGEON REQUESTED TO CREATE A TRAJECTORY TO ONE OF THE BONE FIDUCIALS USED FOR REGISTRATION AFTER BEING CONCERNED THE HEAD HAD MOVED. WHEN DRIVING TO THE FIDUCIAL TRAJECTORY, IT WAS NOTICED THE TRAJECTORY WAS OFF FROM THE FIDUCIAL. SURGEON UNDRAPED AND REREGISTERED. REGISTRATION AND VERIFICATION WERE SUCCESSFUL. SURGEON USED TWO FIDUCIAL TRAJECTORIES TO CHECK THAT WE WERE ACCURATE. AFTER DRILLING THE SECOND BURR HOLE, THE SURGEON DROVE BACK TO ONE OF THE FIDUCIAL TRAJECTORIES TO CHECK WE HAD NOT MOVED. THE TRAJECTORY WAS OFF AGAIN. SURGEON HAD TO UNDRAPE AND REREGISTER A THIRD TIME. THE SECOND LEAD WAS PLACED AND INCISIONS WERE CLOSED. IT IS SUSPECTED THE RADIOLUCENT HEADFRAME ALLOWED THE HEAD TO MOVE. OVER 90 MINUTES WAS ADDED TO THE SURGERY DUE TO THE REREGISTRATION TIME. NO ADDITIONAL PATIENT IMPACT WAS REPORTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211869 ROSA ONE BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS N/A 03760244030948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown