MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VELYS ROBOTIC-ASSIST STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451611001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the l2-l4 mis pedicle screw case.The doctor started l2-l3 on the right side.He stated that he felt that the knife jig was not helping him get the proper trajectory so he transitioned from using the robot to freehand placement for the incision for l4 right.He continued freehand placement on l2 left to l4 left.The final x-ray found and an o-arm spin confirmed that the left l2 screw was both high and lateral compared to plan.They completed another spin, replanned the left l2 with the navigation and robot and the revised placement was acceptable to the surgeon.It was approximately a 60 minutes delay.All information has been disclosed.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d10 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: investigation summary according to the information received, the issue with the following product: 451611001 sn: (b)(6) was experienced: l2-l4 mis pedicle screw case.The doctor started l2-l3 on the right side.He stated that he felt that the knife jig was not helping him get the proper trajectory so he transitioned from using the robot to freehand placement for the incision for l4 right.He continued freehand placement on l2 left to l4 left.The final x-ray found and an o-arm spin confirmed that the left l2 screw was both high and lateral compared to plan.They completed another spin, replanned the left l2 with the navigation and robot and the revised placement was acceptable to the surgeon.Results received from the engineering team (uploaded under related (b)(6): issue #2 investigation summary: the investigation confirmed the allegation "left l2 screw was both high and lateral compared to plan" the investigation was conducted by tpm team.The investigation showed that the correct log file was identified.The were no defects found with the device, and logs confirmed the device monitored excessive forces applied on the robotic arm, but user elected to proceed with screw placement despite displayed alerts.These excessive forces are more likely linked to a skiving of the screwdriver during screw insertion.The images and video were reviewed as a part of the investigation, and they support the overall investigation outcome.As per (b)(4), the fse tested the system and all testing passed.The system is performing to specifications.Root cause: the most probable root cause can be linked to user error.No defect was found with the system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review no manufacturing record evaluation required as no manufacturer or service-related issue found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VELYS ROBOTIC-ASSIST STATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23406346
• Report Number: 1526439-2025-01381
• Device Sequence Number: 8791362
• Product Code: OLO
• UDI-Device Identifier: 10705034646008
• UDI-Public: (01)10705034646008
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K233228
• 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

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 Catalogue Number: 451611001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 12/05/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/03/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RI INCISION TUBE 14.; VELYS CAMERA STATION.; VELYS NAVIGATION STATION.
• Patient Sex: Unknown