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	07/09/2025
Type of Reportable Event	Malfunction
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
It was reported that all four leads were anterior relative to the planned trajectories.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; h2; h3; h6.The reported event could was confirmed.Technical review and physical evaluation: the log file investigation could not confirm an electrode entry discrepancy >2mm.The logs did show the user attempted registration nine times, with one attempt greater than the system's 1mm threshold.The following facts were identified in the logs: fusion: there were no issues found with the exams provided.The merged pre-op mri and ct exams appeared fine.A post-operative exam could not be found in the patient folder.A ct exam taken after electrode positioning was found showing only two electrodes placed.Merging this ct exam to the pre-operative ct showed no displacement.Registration: manual registration was performed with a pointer probe nine times.Only one registration performed was above the threshold of 1 mm.The final registration was acceptable (rms error 0.62).Verification: only three of the seven points taken were within the system¿s 2 mm threshold.The software notified the user that ¿a significant error has been detected on this point¿ for all verification points that were above the 2mm threshold.The user chose to validate the high errors and proceed with the case.Review of the registration verification screenshots indicate that verification was not performed on the recommended anatomical points.Electrode deviation - entry point: the distance between the entry points of the placed electrodes and the planned entry points were analyzed on the ct-bone exam (¿oarm mid¿).There was no ct exam provided for the post -operative view, thus not all electrodes were captured.For the electrodes which were visible, the average deviation for the electrodes were under the system¿s 2mm specification limit.There were no software anomalies identified which caused or contributed to the reported event.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.
Event or Problem Description
No further event information available at the time of this report.

• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22723040
• Report Number: 3009185973-2025-00009
• Device Sequence Number: 9664277
• Product Code: HAW
• UDI-Device Identifier: 03760244034793
• UDI-Public: (01)03760244034793
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231103
• 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
• Report Date (Section B): 03/19/2026

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: 3.1.6.490
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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