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

Model Number	N/A
Medical Device Problem Codes	Communication or Transmission Problem (2896); Connection Problem (2900); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while performing an seeg case, the arm started drifting towards the patient instead and flipping upside down after being put into 'free and fast' mode after trajectory number 5.They stepped off the pedal and tried again to step on the pedal and move away, but it again 'autonomously moved' towards the patient.At this point the arm was up against the patient¿s head.The black force sensor cable was pinched between the patient¿s head and the silver joint behind the force sensor.The robot at this point detected a collision and forced a restart.The arm would not reconnect when the restart was completed.A full shut down was attempted at this point as well, and the arm would not reconnect.Robot was disconnected from the patient remainder of the case was aborted.Once the robot was disconnected from the patient, the drape and instrument holder were removed from the arm.The driver tried to reconnect the rosa arm through the rosa brain application with no success.The robot was shut down and put aside until a rosa team member is able to get onsite to evaluate the situation.Surgery was completed with rosa approximately week later once the repair was completed; there was no other impact to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed and the investigation has been completed, a follow-up mdr will be submitted.
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 updated/corrected updated: b1, d4; d9, h2; h3; h4; h6.The force sensor cable was returned for analysis.The problem could be reproduced with the cable in conditions close to the ones observed in the complaint.Prior to the start, the unit was set to cooperative mode and the arm was positioned in a way that caused the distance sensor cable to push on the force sensor cable.Once the vigilance device was pressed, the arm moved downward autonomously.Normally, the arm would not move in these conditions unless the user was applying a force to the end of the arm.However, functional tests were performed on the returned cable, which confirmed that it was damaged at the level of the force tourqe sensor connector (contacts).Examination shows that with an external software (atidaq) we can observe that the data from the sensor are disturbed when an external force is applied to the cable.When the force sensor cable is pushed, the contact is opened, and this is viewed as if a force was applied on the force sensor.The problem appears only in some positions, and this can explain why the problem happens by intermittence and not in every positions.The sw interprets correctly the received signals, but the information transmitted are erroneous because of the microcut at the level of the connector.The damaged cable is confirmed, and the applicative software is not at stake in this complaint according to this investigation.Per work order the force sensor cable was replaced approximately a day after this reported event.Following this repair, a full preventative maintenance (pm) was performed.The unit passed all final servicing verifications and was released for clinical use.Based on the investigation, the unintended arm drifting was caused by a combination of factors, specifically an external force being applied to a damaged force sensor cable.However, the root cause for the damage to the force sensor cable cannot be determined.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.This supplemental report is to add information for h10 for an additional medwatch that was submitted by the user.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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: 20077721
• Report Number: 3009185973-2024-00010
• Device Sequence Number: 7561880
• Product Code: HAW
• UDI-Device Identifier: 03760244034793
• UDI-Public: (01)03760244034793
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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?: 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: L041524
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 12/03/2024; 07/22/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/25/2024; 12/12/2024; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: Other; Hospitalization
• Patient Sex: Unknown