MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN + SPINE

Model Number	ROSA ONE 3.1
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Zimmer biomet medtech has been made aware of a serious adverse event that occurred at the (b)(6), in with robot s/n (b)(4).A systematic registration error appeared to be present with an intraoperative o-arm spin.The day of these case, wednesday 27th of october, an inaccuracy occurred.On the following day, the 28th, the patient had an intraparenchymal hematoma of about 2 cm in size.The patient is anticipated to make a full recovery.
Additional Manufacturer Narrative
Dhr review and review of complaint history did not identify any contributory factors to the event.The preliminary analysis of software logs and patient files revealed that the contactless registration was performed correctly before surgery, although no entry point was verified with the distance sensor before going to guidance.The fusion shows no issue.An inaccuracy of 3.5mm to 4.5mm is confirmed for the first six trajectories implanted.Then, a second registration was performed with the pointer probe.After this registration, the other five trajectories were implanted.These trajectories seem to be accurate, although this could not be confirmed because the post-operative scan showing these trajectories was not provided for analysis.At this point, our analysis shows no malfunction of the device.Medical device: udi#: (b)(4).
Additional Manufacturer Narrative
A full analysis of the data logs has been performed and concluded that an inaccuracy of 3.5mm to 4.5mm is confirmed for the first six trajectories implanted.The contactless registration was performed correctly, although no entry point was verified with the distance sensor before going to guidance which is recommended in the instructions for use.The fusion between the pre-operative mri and ct exams showed a small shift, but this could not explain the electrode placement inaccuracy.The inaccuracy of the six electrodes could be due to an undetected movement of the head following the registration.Then, a second registration was performed with the pointer probe.The registration accuracy was not correctly verified and markers were incorrectly placed.Recommended placement of markers is written in the instructions for use.After this registration, the other five trajectories were implanted.These trajectories seem to be accurate, although this could not be confirmed because the post-operative scan was not provided for analysis.Analysis shows no malfunction of the device.
Event or Problem Description
Zimmer biomet medtech has been made aware of a serious adverse event that occurred at the houston va, in with robot s/n (b)(6).A systematic registration error appeared to be present with an intraoperative o-arm spin.The day of these case, wednesday (b)(6), an inaccuracy occurred.On the following day, the (b)(6), the patient had an intraparenchymal hematoma of about 2 cm in size.The patient is anticipated to make a full recovery.

• Brand Name: ROSA ONE BRAIN + SPINE
• Common Device Name: ROSA ONE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12882859
• Report Number: 3009185973-2021-00182
• Device Sequence Number: 20018622
• Product Code: HAW
• UDI-Device Identifier: 03760244033765
• UDI-Public: (01)03760244033765
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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 3.1
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1652
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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
• Patient Sex: Unknown