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

Model Number	ROSA ONE 3.1
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
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.Udi# : (b)(4).
Event or Problem Description
During the dbs procedure multiple o-arm spins were merged to the first bone fiducial o-arm spin.Only the last o-arm spin presented a merge issue.The latest ct scan was rotated 90 degrees overlaying the fiducial o-arm spin.Adjustments were made using the rotation and translation tools, however after recalculating, the system immediately reverted to the original 90 degree mis-orientation.Since the scans were not merging correctly after recalculating, it was attempted merging the last o-arm cst to the original planning mri.This merge presented no issues and after careful observation the surgeon accepted the merge on the software.These last o-arm spins during the operation confirmed accurate electrode placement.However, 2 weeks post-operation surgeon contacted zimmer biomet claiming the ct scans obtained after procedure and o-arms during procedures do not match resulting in inaccurate electrode placement.Customer is requesting an investigation to determine if the merging software contributed to inaccurate electrode placement.Patient impact is unknown however surgeon indicated a revision surgery may be necessary.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.A full analysis of the provided log files was performed.While the automatic fusion result was insufficient and required manual adjustment, the device is considered to have performed as per specification.However the failure of the manual adjustment feature to provide an acceptable result is a known software anomaly.A performance improvement opportunity for the automatic fusion algorithm is already being worked on.Regarding the inaccuracy issue, the analysis concluded that the prior surgery, led to an accurate placement of electrodes with rosa.The review performed 2 weeks later seemed to have been performed on a distorted ct.The revision surgery showed that the replaced electrode was shifted over 2mm at the entry point but was accurate at the target point.However, this replacement was performed on purpose.The device operated as intended in regards to the reported inaccuracy issue.Therefore with no inaccuracy identified, the mentioned fusion issues are not considered to have caused or contributed to the reported inaccuracy.The functionality and accuracy of the subject rosa brain device was verified during a preventive maintenance.No issues related to the reported event were observed, all tests and checks passed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the reported event and the relationship of the product, if any, to the reported incident or adverse event and justification used to make the decision.Based on the investigation performed, no failure of the device was found for the inaccuracy issue.Fusion issues are related to performance improvement and software anomaly but are not considered to have caused or contributed to the reported inaccuracy.A corrective action has been previously initiated for the reported event.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
During the dbs procedure multiple o-arm spins were merged to the first bone fiducial o-arm spin.Only the last o-arm spin presented a merge issue.The latest ct scan was rotated 90 degrees overlaying the fiducial o-arm spin.Adjustments were made using the rotation and translation tools,however after recalculating, the system immediately reverted to the original 90 degree mis-orientation.Since the scans were not merging correctly after recalculating, it was attempted merging the last o-arm cst to the original planning mri.This merge presented no issues and after careful observation the surgeon accepted the merge on the software.These last o-arm spins during the operation confirmed accurate electrode placement.However, 2 weeks post-operation surgeon contacted zimmer biomet claiming the ct scans obtained after procedure and o-arms during procedures do not match resulting in inaccurate electrode placement.Customer is requesting an investigation to determine if the merging software contributed to inaccurate electrode placement.The patient was revised approximately 1.5 months later.No further event information available at the time of this report.

• Brand Name: ROSA ONE
• 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: 14733829
• Report Number: 3009185973-2022-00034
• Device Sequence Number: 20345508
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)190911
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: 3.1.5.28
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown