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	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the during a litt case, it was noticed from a confirmation scan that the trajectory of the implanted medtronic visualase laser catheter was 2mm lateral of the planned trajectory.A new trajectory was created, and another instrument holder was used to re-insert the laser.The same issue was seen after re-insertion.Surgeon moved forward with the placement.Doro radiolucent mayfield adapter was checked to be stable when connected to robot.A good fiducial registration was attained and verified for optimal accuracy.Entry point was marked before incision and aligned with drilling sight.Arm was locked during drilling, and laser catheter was placed with care to introduce no deviation.New software has been installed on the system.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: d4; h2; h3; h6 the rosa brain system log files were sent back for investigation and analyzed by a subject matter expert (sme).Based on the data analysis, the reported electrode placement inaccuracy is confirmed.Both the initial and re-inserted electrodes were >2mm off their planned entry points.The following facts were identified in the logs: - the user performed manual bone fiducial registration with the pointer and achieved a passing rms result of 0.52mm.- the registration verification was completed with multiple validation points that exceeded the device specification limit of 2mm.The logs show the software notified the user that ¿a significant error has been detected on this point¿ for the four verification points that were above the 2mm threshold.- the marker placement, specifically markers 2 and 3, appear to be close together and almost on the same plane.This can impact the verification results and contribute to high verification values.There were no software anomalies identified which would have caused or contributed to the reported event.In the user manual, it recommends that if too high of an error is detected on a point during the verification process, the user should visually check the point and redo registration, if necessary.In this case, the user chose to validate the high errors and proceed with the case, which is not advised.It shows that the registration verification accuracy was not optimal, which could have contributed to the electrode inaccuracy.Through correspondence with the cst, the head holder used for the litt procedures at this hospital was replaced, and it was noted that no further inaccuracy issues have been seen since the replacement.The head holder used during surgery, and the replacement currently in use, are not zimmer biomet products but are compatible with rosa one.Although an issue with the head holder could have caused a trajectory discrepancy, it cannot be confirmed with the information currently available.A rosa one technician was on-site to assess the functionality and accuracy of the rosa unit used during the case.The unit was confirmed to be in working order as all accuracy and applicative tests passed.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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.

• 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: 16751083
• Report Number: 3009185973-2023-00012
• Device Sequence Number: 12918433
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)181116
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 3.1.6.276
• Was Device Available for Evaluation?: No
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2018
• 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
• 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: Unknown