MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN; ROBOTICS, BRAIN

Model Number	N/A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 the university of kansas performed a seeg.After getting a post operation scan, the accuracy was noted to be significantly off.Registration was reported to be acceptable.When checking the post operation merge, it was noted that the frame pins were in a different location, suggesting the patients head slipped in the pins.The trajectories were significantly off at the entry and target points.No negative impact to the patient was reported.No additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of software logs.The associated software logs were and analyzed by a subject matter expert.Based on the logs and the electrode measurement analysis performed, the reported electrode placement inaccuracy is confirmed.All electrodes ranged between 3-8mm off their planned entry points and around 3-10mm off their planned target points.The analysis concluded the following: manual bone fiducial registration was performed with the pointer and accurate results were achieved.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 three verification points that were above the threshold.All the trajectories appear to have been shifted above their respective planned trajectories, towards the top of the patient¿s head.¿ the patient head holder frame pin locations between the pre-op and post-op images were analyzed, and indeed, the back right and left frame pin placements appear to have been shifted.In the sagittal and coronal views, the pre-op pin position is shown to be lower on the patient¿s head compared to the post-op pin placement.Therefore, it is likely a movement between the patient¿s head and head holder frame occurred at some point in between taking the pre-op and post-op images.The cause for this movement cannot be determined with the information available.There were no software anomalies identified which would have caused or contributed to the reported event.Section 4.6.3 accuracy verification procedure of the dbz-041b-us 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 2.4.2 accuracy verification procedure of the dbz-041b-us brain application user manual provides adequate instructions on performing verification to obtain optimal system performance.Regarding the target point deviation, the insertion of electrodes is under the surgeon¿s control and can be impacted by factors which are independent from the robot, such as material stiffness, patient¿s anatomy, implantation method, etc.Based on the investigation, the 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.
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 information at the time of this report.

• Brand Name: ROSA ONE BRAIN
• Common Device Name: ROBOTICS, BRAIN
• 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: 18355367
• Report Number: 3009185973-2023-00025
• Device Sequence Number: 12364099
• Product Code: HAW
• UDI-Device Identifier: 03760244034793
• UDI-Public: (01)03760244034793(11)221220
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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?: 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: 12/04/2023
• Supplement Date Received by Manufacturer: 05/15/2024; 07/22/2025
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 05/16/2024; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown