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

Catalog Number	ROSAS00203
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The associated software logs were provided to the post market surveillance team and analyzed by a subject matter expert (sme).Based on the logs and the electrode measurement analysis performed, a trajectory inaccuracy was identified.The average electrode deviation was 7.05 mm off of the planned entry point.The following facts were identified in the logs: the user performed manual bone fiducial registration with the pointer and achieved a passing rms (root mean square) result.The registration verification was completed with multiple validation points that exceeded the device specification limit.The logs show the software notified the user that ¿a significant error has been detected on this point¿ for the four verification points that were above the threshold.Based on the registration verification screenshots taken by the software, step 3 was performed on a bone fiducial, which is not recommended.No issues were observed in the fusions between the mri planning exam and the ct exam used for registration.No shift was observed between the pre op and post op ct exams.The trajectory measurement analysis was performed by the sme on the post op ¿postop oarm¿ ct exam.The actual trajectory deviated from the planned trajectory by 7.05 mm, which is above the specification limit of the system.There were no software anomalies identified which would have caused or contributed to the reported event.Accuracy verification procedure section of the dbz brain application user manual recommends that if too high of an error is detected on a point during the verification process, the user should visually check the point and redo registration, if necessary.In this case, the user chose to validate the high errors and proceed with the case, which is not advised.Additionally, section accuracy verification procedure of the dbz brain application user manual provides adequate instructions on performing verification to obtain optimal system performance.A field service engineer (fse) went on-site after the reported event for a regular preventative maintenance (pm).The fse performed a full preventive maintenance, and all tests passed.The unit was confirmed to be in working order.Device history records were reviewed and no discrepancies related to the reported event were found.Based on the investigation performed, the root cause for the internal brain bleed cannot be determined.While a trajectory inaccuracy and some user errors were identified during the registration and verification process, it cannot be confirmed if these issues caused or contributed to the reported brain bleed.No issues were found with the rosa unit or rosa software.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.
Event or Problem Description
It was reported that a patient that was operated for a deep brain stimulation (dbs) procedure and had an internal brain bleed following the procedure.The specific procedure performed was removal of existing dbs hardware and placing one new electrode, unilaterally.It was discovered after the post op ct scan that an internal bleed had occurred, either during the removal of the existing hardware, or implantation of new hardware.The new dbs electrode that was implanted was manufactured by medtronic.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 34130 ; FR 34130
• 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: 22891716
• Report Number: 3009185973-2025-00010
• Device Sequence Number: 5828525
• 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: K214065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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: 07/29/2025
• Initial Report FDA Received Date: 08/25/2025
• 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