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

Model Number	N/A
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	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A full analysis of the data logs was performed.The logs confirmed the inaccuracy for the entry points of the seven of the fourteen electrodes.The following facts were identified in the logs: the pre-op ct ¿ct bone fiducial¿ and the mr ¿pre-implantation t1mprage¿ exams were merged to check for visible shift during fusion.No significant shift was observed.The user performed manual bone fiducial registration with the pointer and achieved a passing rms.The bone fiducial placement was not optimal.The fiducials were not located near the area of interest and were localized to one side of the patient¿s head.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.The trajectory measurement analysis was performed by the subject matter expert (sme) on the post-op ct exam "post4".Seven of the fourteen electrodes deviated from their planned trajectories by more than the threshold.The maximum average deviation was above the threshold.There were no software anomalies identified which would have caused or contributed to the reported event.Bone fiducials registration of the user manual brain application provides the following guidance on bone fiducial placement: ¿the markers must be distributed over the patient's head non-symmetrically and should not be placed in the same plane.It is recommended to place the fiducials near the area of interest and to avoid areas of the head that might move during the procedure.¿ accuracy verification procedure of the 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, accuracy verification procedure brain application user manual provides adequate instructions on performing verification to obtain optimal system performance.A field service engineer (fse) went on-site about a month prior to 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.The definitive root cause cannot be established with the information available.However, user errors in the bone fiducial placement and registration verification were identified.The rosa one brain application user manual provides information on the methods for registration and warns user that registration error can cause inaccuracies in section registration methods.Section registration details the procedure to perform a registration and verification.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, following electrode implantation, an o-arm scan was taken to confirm electrode location.All the electrodes appeared inaccurate by a few millimeters, with two being subdural.The two subdural electrodes were removed and replaced once the dura was reopened.After looking closer at the merge, it appeared slightly off.The merge was redone multiple times with the pre-op ct ¿ctbonefiducial¿ and mr ¿pre-implantation timprage¿ but was still off, and was ultimately adjusted manually, which resulted in the electrodes appearing more accurate.In addition, a trajectory was made at one of the bone fiducials to confirm the patient hadn¿t shifted and the robot remained accurate and the trajectory to the fiducial was spot on.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: 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: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 21047235
• Report Number: 3009185973-2024-00022
• Device Sequence Number: 16996544
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)180313
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• 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: 3.1.6.432
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown