MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN; MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM

Catalog Number	ROSAS00203
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post op ct was merged with preop ct and mri and the entry points of all trajectories were 3-4mm off but the targets were all relatively on trajectory.Laser registration was performed and verification was accurate.Confirmed that the patient was still securely in pins/did not move.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were (update/corrected).Corrected: g4.Updated: g3; h2.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The following sections were updated/corrected updated: d4; h2; h3; h6.A full analysis of the data logs was performed.The logs confirmed the electrode inaccuracies.There was a shift of the electrode¿s trajectories, with the left side more anterior and superior to the planned trajectories and the right side more posterior and inferior to the planned trajectories.This could indicate head movement, but this cannot be confirmed to be the main contributor of the discrepancies seen.Registration and verification steps were performed per procedure.Registration laser rms (root mean square) error was under the threshold.Percent of matched points was 100%.However, review of the screenshots provided shows that the laser appears to go beneath the skin of the 3d render on the right side of the patient¿s face.This could indicate a discrepancy between the patient and the reference exam.Exam "ct: ct" was merged with reference exam "exam 1: mr" using the automatic merge function prior to the procedure.The logs indicate that the fusion was validated by the surgeon without adjustments.This fusion was recreated in simulator.No issue was observed with the merge.The merge between the post op ct and pre op ct was also recreated, but there appeared to be some blurriness and misalignment between the two.Review of the 3d render of the post-op ct found several artifacts and gaps.It cannot be determined if this merge issue was due to a head shift or poor exam quality.There were no software anomalies identified which would have caused or contributed to the reported event.Device history records were reviewed and no discrepancies related to the reported event were found.Based on the investigation, the reported event was verified, but 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.

• Brand Name: ROSA ONE BRAIN
• Common Device Name: MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21878312
• Report Number: 3009185973-2025-00006
• Device Sequence Number: 15638874
• Product Code: HAW
• UDI-Device Identifier: 03760244034793
• UDI-Public: (01)03760244034793
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K214065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.6.432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 07/31/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/22/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown