MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the instrument is not able to be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the doctor attempted marker registration and received an rms higher than usual.After verification, the anatomical markers and one fiducial marker appeared shifted.Marker registration was attempted a 2nd time with similar results.It appeared the front right frame pin had become loose on the patient after the initial airo ct scan.The image showed the pin on the edge of bone.The pin was repositioned, a new airo ct scan was taken, and marker registration was performed a 3rd time.Registration appeared more acceptable and normal.The lead inaccuracy on the left was left by the surgeon.The lead on the right was adjusted due to concern of side effects.A delay of 45 minutes was recorded.The case continued and a post scan of the l gpi was taken showing an error of 1.5mm posterior lateral.A scan of the r gpi was taken showing an error of 1.5mm posterior medial.This right lead was moved creating another 20-minute delay.No negative patient impact was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4; g1-2; h2; h3; h4; h6.It is noted for udi in d4 and h4 have different manufacturing dates.Manufacturing date in h4 reflects the last software revision.Manufacturing date in udi reflects the devices manufacturing date.A full analysis of the data logs was performed.The logs did not confirm an inaccuracy or the inaccurate position of the pin during registration.The distance between the entry points of the placed electrodes and the planned entry points were analyzed on the post-op ct-bone exams.The average deviation for all electrodes were under the system¿s 2mm specification limit.Marker registration was performed four times, all of which had acceptable results (<1mm).However, it was identified the registration verification was not performed correctly, and the user validated high registration verification errors, which is not advised.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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 2.4.1 (registration methods).Section 4.6 (registration) details the procedure to perform a registration and verification.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ROSA ONE BRAIN
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21091419
• Report Number: 3009185973-2025-00001
• Device Sequence Number: 18323243
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)191128
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/23/2025

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: N/A
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 04/11/2025; 07/23/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 04/25/2025; 07/24/2025
• 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