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

Model Number	N/A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the case was aborted as the robot arm was unable to connect to the controller.Starc card slot changed with no success.A replacement starc card has been ordered.Case had to be aborted after patient had bone fiducials placed.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.A follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).The investigation found the internal components inside the staubli controller, the central processing unit (cpu) board, had failed.The cpu board was replaced, and a full preventative maintenance check was performed.The unit passed all tests, and the issue was resolved.The unit was re-installed at customer location.A complete preventative maintenance was performed.The system passed all tests.The system was functional as per specifications and ready to be used.Device history record was reviewed and no discrepancies relevant to the reported event were found.The definitive root cause for the cpu board malfunction 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 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: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 20533044
• Report Number: 3009185973-2024-00015
• Device Sequence Number: 8465501
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)180413
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Non-Healthcare Professional
• 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?: Yes
• 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 07/23/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/16/2024; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown