BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE BRAIN

    MDR report key: 21223802 · Received January 23, 2025

    Report

    Report Number
    3009185973-2025-00002
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    July 25, 2024
    Report Date
    July 23, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K214065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LOG FILES FROM THE EVENT DATE WERE NOT AVAILABLE FOR REVIEW. WITHOUT LOG FILES, THE REPORTED CALIBRATION ERRORS CANNOT BE CONFIRMED FOR EVENT DATE. THE DEVICE WAS SPORADICALLY HAVING ISSUES WITH THE FORCE SENSOR CALIBRATION. THE UNIT WAS SENT TO RETURNS DEPARTMENT FOR EVALUATION AND DURING A CORRECTIVE MAINTENANCE PERFORMED APPROXIMATELY 3 MONTHS AFTER THIS EVENT, IT WAS NOTED THE FORCE SENSOR HAD LOOSENED, WHICH COULD RESULT IN THE ISSUES REPORTED IN THIS COMPLAINT. THE DAQ CARD WAS ALSO REPLACED, WHICH IS RESPONSIBLE FOR THE COMMUNICATION WITH THE FORCE SENSOR AND ALSO CAN CONTRIBUTE TO THE REPORTED CALIBRATION ISSUE. AFTER REPAIRS, THE UNIT WAS SENT BACK TO THE CUSTOMER LOCATION AND ALL TESTS PASSED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE (UPDATE/CORRECTED). CORRECTED: G4. UPDATED: G3; H2.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY; THE ROBOT WAS ABLE TO CALIBRATE THE EMPTY ARM BUT FAILED TO CALIBRATE THE POINTER PROBE. RECALIBRATION EMPTY WAS PERFORMED SUCCESSFULLY AND THEN POINTER PROBE CALIBRATED SUCCESSFULLY. ARM WAS THEN DRIVEN TOWARDS FIDUCIALS. ARM BEGAN TO DRIFT IN FAST MODE WITH NO MANUAL INPUT. FULL POWER DOWN WAS PERFORMED AND ISSUED PERSISTS. PROCEDURE WAS ABORTED AFTER IMPLANTATION OF BONE FIDUCIALS THAT WOULD REQUIRE CLOSURE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742351 ROSA ONE BRAIN MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM HAW MEDTECH SAS UNKNOWN 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization