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	02/22/2023
Type of Reportable Event	Malfunction
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
It was reported after a seeg case, it was noticed all of the electrode placements were off a fair amount.Additionally, there were some registration errors during the case due to the fact that one of the fiducials was right on top of a trajectory, this lead to them deciding to utilize only 4 out of 5 bone fiducials for registration.The first bone fiducial registration they did got an rms of 1.00 as they did 4 out of 5 of the fiducials and then validated.The second time they did registration they deleted the fifth bone fiducial completely so registration utilized only 4 out 4 of the bone fiducials.It was noticed that these trajectories were still off by a good amount post-surgery.It was noticed that one of the fiducials had shifted after looking at the scan.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.Preventive maintenance passed prior to case.No maintenance has been performed following the event.However, more than 10 other surgeries using bone fiducial registration were performed after the case and passed with no other similar event reported.A full analysis of the data logs has been performed and confirmed the reported event.Several facts/issues were identified, all likely contributing to the reported inaccuracy: patient head motions: at least one head motion was proven: the coordinates on which the robot was sent at the beginning of the operation and at the end are the same relative to the robot but are different relative to the patient.The definitive cause for the movement cannot be determined with the information available.Incorrect fiducial positioning: markers are all on the left side (so not distributed over the patient head).Additionally, all of them are close to in one sagittal plane.Moreover, several trajectories are on the far-left side and no fiducials are close to this area of interest.Not enough bone fiducials: there were only 4 fiducials used during this surgery.Incorrect verification: the user skipped the verification steps required by rosanna.The serial number of this device was reviewed for any deviations and/or anomalies in the servicing/maintenance process that may have contributed to this reported event.No deviations or anomalies were discovered.Based on the investigation performed, the technical root cause of the patient head shift(s) cannot be determined with the available information.The root cause of the bone fiducial and verification issues is related to user error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: 16584229
• Report Number: 3009185973-2023-00009
• Device Sequence Number: 14626322
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)160517
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/19/2023

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: 3.1.6.90
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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