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

Catalog Number	ROSAS00203
Medical Device Problem Codes	Failure to Calibrate (2440); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during surgery; the robot was able to calibrate the empty arm but failed to calibrate the pointer probe.Recalibration empty was performed successfully and then pointer probe calibrated successfully.Arm was then driven towards fiducials.Arm began to drift in fast mode with no manual input.Full power down was performed and issued persists.Procedure was aborted after implantation of bone fiducials that would require closure.
Additional Manufacturer Narrative
(b)(4).Log files from the event date were not available for review.Without log files, the reported calibration errors cannot be confirmed for event date.The device was sporadically having issues with the force sensor calibration.The unit was sent to returns department for evaluation and during a corrective maintenance performed approximately 3 months after this event, it was noted the force sensor had loosened, which could result in the issues reported in this complaint.The daq card was also replaced, which is responsible for the communication with the force sensor and also can contribute to the reported calibration issue.After repairs, the unit was sent back to the customer location and all tests passed.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.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 event information available 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: 21223802
• Report Number: 3009185973-2025-00002
• Device Sequence Number: 18276330
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)180813
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/23/2025

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 Catalogue Number: ROSAS00203
• Device Lot Number: UNKNOWN
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown