MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

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	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3009185973-2023-00015.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
It was reported that during a seeg procedure, the optical distance sensor did not accurately drive to the intended trajectory to mark the entry site.The intended trajectory was proximal to the patient¿s right ear but the laser drove distal to the right ear.The laser was swapped out with the pointer probe and rosa correctly drove to the trajectory.At this time, we also navigated the pointer probe back to the bone fiducials to re- verify the registration and rosa was still correctly registered to the patient¿s position.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The associated system log files were provided and reviewed by a subject matter expert.The logs confirm the reported event and conclude that the distance sensor parameters were ignored when the user drove to the trajectory because its re-connection was never validated.This behavior is known as design defect.Review of the servicing records for rosa unit found that distance sensor has failed accuracy checks during the preventative maintenance sessions before and after event date.Despite having issues with the optical distance sensor tests, the feild service engineer was able to confirm the functionality of the rosa system as the robot correctly passed both the accuracy and applicative tests using marker registration with the pointer probe.The remainder of the system still met all functional requirements when it was released back to the customer.However, the optical distance sensor should have been quarantined after the initial failed testing.A capa has already been initiated and includes planned revisions of rosa one servicing quarantine process.Design defect occurs while the robot arm is driving towards a trajectory, and before the optical distance sensor takes its measurements.Regardless of whether the distance sensor has accuracy issues, the software failure would have still occurred.Therefore, return and subsequent evaluation of distance sensor will not affect investigation results.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was determined due to be a software anomaly.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.

• Brand Name: ROSA ONE BRAIN
• Common Device Name: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• 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: 17011520
• Report Number: 3009185973-2023-00016
• Device Sequence Number: 6872498
• Product Code: HAW
• UDI-Device Identifier: 03760244034304
• UDI-Public: (01)03760244034304
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200511
• 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
• Report Date (Section B): 10/31/2023

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Female