BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 23298746 · Received October 15, 2025

    Report

    Report Number
    3009185973-2025-00013
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    April 8, 2026
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K231103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A2; A3A; B5; D2B; D4; D9; G1; G3; H1; H4; H6. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. THE LOGS SHOW THE USER RESTARTED THE DEVICE MULTIPLE TIMES AND THERE WERE CONTROLLER CONNECTION ERRORS. A REVIEW OF ROSA LOGS DID NOT IDENTIFY ANY SOFTWARE ANOMALIES WHICH MAY HAVE CONTRIBUTED TO THE EVENT. PER JIRA RECOMMENDATION, THE E-STOP AND KA4 RELAY WERE REPLACED BUT THIS DID NOT FIX THE ISSUE. THE AUXILIARY ROBOT POWER SUPPLY (ARPS) WAS REPLACED IN THE CONTROLLER, AND THIS ALLOWED THE ROBOT TO THE CONNECT TO THE ARM SUCCESSFULLY AND THE E-STOP SHUTS DOWN WHEN IT IS FULLY DEPRESSED. HOWEVER, THE E-STOP RED LED LIGHT WILL NOT TURN OFF EVEN WHEN NOT ENGAGED AND THE KA4 RELAY WAS ALSO STAYING OFF. JIRA HAS RECOMMENDED TO REPLACE THE E-STOP ASSEMBLY, BUT THIS PART IS CURRENTLY UNAVAILABLE AND WILL BE REPLACED WHEN IN STOCK. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE EMERGENCY STOP WILL NOT DISENGAGE. THEY WERE UNABLE TO CONNECT TO THE ROBOT ARM AND HAD TO ABORT THE SURGERY. THE PATIENT WAS UNDER ANESTHESIA FOR A FEW HOURS, PINNED IN A HEADFRAME, AND THE HEADFRAME WAS ATTACHED TO THE ROBOT. THE PROCEDURE WAS RESCHEDULED. 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
    1211 ROSA ONE BRAIN NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTECH SAS 3.1.6.490

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Other