MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number	N/A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an rns implantation surgery, after placement of both leads (trajectories ¿r amygdala¿ and ¿r hippocampus¿) an o-arm ct scan was taken and merged to the registration ct.The ¿r hippocampus¿ lead was superior to the planned trajectory by about 5 mm.The ¿r amyglada¿ lead was minimally superior and anterior to the planned trajectory, but was determined to be satisfactory.A new trajectory was planned to replace ¿r hippocampus¿.This new trajectory (¿trajectory 1¿) was planned inferior to the ¿r hippocampus¿ trajectory.The lead was removed and re-placed at ¿trajectory 1¿.Another o-arm ct scan was taken and merged to the registration ct.The lead was also about 5 mm superior to ¿trajectory 1¿ and about 3 mm superior to ¿r hippocampus.¿ the surgeon determined that the lead placement was sufficient and did not need further improvement.Surgeon also noted that it was possible the head had moved in the clamp, as there was some slight movement to the head fixation.No other issues occurred during the procedure and this resulted in a 30 minute delay to the case.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.Investigation of the log files was performed by the zimmer biomet product surveillance team subject matter expert (sme).Results of the log file investigation did confirm the reported event.No software anomalies were identified which may have contributed to the event.The registration verification screenshots were not provided to confirm the accuracy of the points placed.Validation was not performed properly; thus, it cannot be confirmed if the registration was completely accurate.All the reported electrode placement inaccuracies are confirmed.An adjustment did occur for the second post ct scan and a deviation >2mm was seen.The deviation analysis and notes form the surgeon suggests there was head movement with a center of rotation close to the temporal right side which can be a potential cause of the inaccuracies seen.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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
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 information at the time of this report.

• Brand Name: ROSA ONE BRAIN
• Common Device Name: COMPUTER-ASSISTED SURGICAL DEVICE
• 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: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 17555520
• Report Number: 3009185973-2023-00021
• Device Sequence Number: 3627163
• Product Code: HAW
• UDI-Device Identifier: 03760244033765
• UDI-Public: (01)03760244033765
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 07/22/2025

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 Model Number: N/A
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.6.276
• Was Device Available for Evaluation?: No
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 07/22/2025
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 12/14/2023; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown