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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that velys navigation station, velys robotic-assist station, velys camera station, and velys spine array base set were involved in a reported event during a spinal procedure.The issue was described as two screws being placed 5mm off from the planned position, with the robotic system positioned on the patient's right side.Troubleshooting included conducting a second spin before removing and replacing the screws.There was patient involvement, but no injuries, medical intervention, or prolonged hospitalization were reported.
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).Rep reported an issue of 2 screws that were placed were 5mm off to plan.Rep states that he does not believe the arrays was bumped or moved.Results received from the engineering team: (uploaded under velys navigation station pi-17715554835827357).Investigation summary : investigation summary : log file analysis has been performed by tpm team, from spineclinicalapp-2026.02.18-09h37m16s, using spine log viewer and software clinical application test edition, based on event date and event description matching the reported information.The investigation confirmed the allegation "an issue of 2 screws that were placed were 5mm off to plan".Based on log review, the investigation found that an inaccurate registration was validated, following anatomy checks that was performed on the phantom array showing inaccuracies.Soft tissue pressure was exerted on the robotic arm during instrumentation, and "excessive force" warnings were displayed on the gui, but no actions were taken to allow for a precise screw insertion.Overall, the device behave as expected.At least two use errors led to this screw misplacement: accepting an inaccurate registration (with a non-adapted anatomy check) and instrumenting while soft tissue pressure is exerted on the robotic arm.Beyond surgical delay, the user indicated that there was no reports of injuries, medical intervention or prolonged hospitalization.This issue will be continued to be monitored through complaint trending as part of post market surveillance.Root cause : the most likely root causes for this screw misplacement are accepting of an inaccurate registration (with a non-adapted anatomy check) and instrumenting while soft tissue pressure is exerted on the robotic arm, these factors are traced to improper handling by the user.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: null.Device history batch: null.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: 24586201
• Report Number: 1526439-2026-00247
• Device Sequence Number: 21178714
• Product Code: OLO
• UDI-Device Identifier: 10705034646008
• UDI-Public: (01)10705034646008
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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

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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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
• Patient Sex: Unknown