MAUDE Adverse Event Report: MEDTECH SA ROSA ONE BRAIN + SPINE; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number	ROSA ONE
Medical Device Problem Codes	Positioning Failure (1158); Unintended Collision (1429); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hematoma (1884); Intracranial Hemorrhage (1891); Paralysis (1997)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that it was completed a 13 trajectory bilateral seeg case using the rosa robot with a company representative present.The patient was put to sleep, pinned in a mayfield head clamp, attached to rosa and registered using contactless registration.All 13 trajectories were placed as normal.The company representative then received an email the next day from the surgeon stating that the patient had a brain hemorrhage that was seen on a post operative ct scan.The information that was given was that the majority of the electrodes were placed correctly, but a couple were off target.
Additional Manufacturer Narrative
Dhr review and review of complaint history did not identify any contributory factors to the event.A detailed analysis of the data logs has been performed, and revealed that the fusion of the post-operative ct to the pre-operative ct had not been performed properly by the user.However, proper fusion results could not be achieved using a rosa simulator during our investigations; consequently, the actual placement of the electrodes could not be reviewed and the inaccuracy cannot be confirmed.However, our review of available files did not suggest any issue with the registration process, the pre-operative fusion or the rosa log files.No failure of the device or user error is suspected.The reported inaccuracy remains unconfirmed.
Event or Problem Description
It was reported that it was completed a 13 trajectory bilateral seeg case using the rosa robot with a company representative present.The patient was put to sleep, pinned in a mayfield head clamp, attached to rosa and registered using contactless registration.All 13 trajectories were placed as normal.The company representative then received an email the next day from the surgeon stating that the patient had a brain hemorrhage that was seen on a post operative ct scan.The information that was given was that the majority of the electrodes were placed correctly, but a couple were off target.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional information received from legal documentation and complaint information has been updated.The additional information has not yet been evaluated yet for investigation purpose.Once the additional evaluation is performed and the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported with the use of rosa one brain, seeg procedure was planned and completed with a total of 14 electrode placements.There was a 'robot collision' and the orbitofrontal ('x2 and temporal pole electrode were not placed').It is unknown at what time during the procedure the 'robot collision' occurred.Immediately post operative period it was reported the patient experienced behavior changes, hemiparesis, and ct scan was performed indicating hemorrhage.Approximately two days after surgery, it was noted emergent intubation with progressive leftward shift of hemorrhage was noted and taken to surgery.Seeg electrodes removed.While removing one of the electrodes it was noted there was clot/hematoma activity found.Legal reports ongoing disabilities.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: h2; h3; h6.According to additional information from legal, there was a ¿robot collision¿ during the surgical procedure.The associated investigation log files were analyzed by a subject matter expert.Review of the event log files confirm that a collision was detected in the force sensor and the system gave the user two collision warnings back-to-back.The user was ultimately able to continue the arm movement and completed the case with no further collision messages.The controller logs were reviewed, but no obvious errors were seen.There were no software anomalies identified which would have caused or contributed to the reported event.No other changes were made to the original investigation conclusions.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ROSA ONE BRAIN + SPINE
• Common Device Name: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SA; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12948229
• Report Number: 3009185973-2021-00184
• Device Sequence Number: 4803000
• Product Code: HAW
• UDI-Device Identifier: 03760244033765
• UDI-Public: (01)03760244033765
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2024

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: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.5.28
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 12/10/2021; 02/27/2024; 04/12/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/16/2021; 03/25/2024; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2020
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male