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	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that during spine surgery: t4 to l4, the navigation camera could not visualize robotic arm due to the lack of an extra joint.The trialtus screwdriver lodged after screw release mode and could not remove the screwdriver from tulip head.The screwdriver was removed using slight force.The l4 left screw release mode was excessive due to soft tissue, this caused the screw to be lateral to plan.Freehand navigation was used to replace it.All information has been disclosed.No further information was provided.
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.H11 additional narrative: h3, h6: investigation summary: according to the information received, the issue with the following product: 451611001 w17316323301.Navigation camera was not able to visualize robotic arm due to the lack of an extra joint.- trialtus screwdriver lodged after screw release mode, could not remove screwdriver from tulip head.Screwdriver was removed using slight force.- l4 left screw release mode was excessive due to soft tissue, this caused the screw to be lateral to plan.Freehand navigation was used to replace it.Investigation summary: issue #1: investigation covered under velys camera station (b)(4).Issue #2: issue 2 reported that "trialtis screwdriver lodged after screw release mode, could not remove screwdriver from tulip head.Screwdriver was removed using slight force." the investigation was conducted by the r&d team and based on log review.The investigation showed that the correct log file was identified.Navigation logs review showed that the tulip (screw head) is hitting the bone anatomy, which, as described per robotic integration instruments ifu, highlights that it "could cause difficulty when removing the screw", matching the exact reported situation.To help in the withdrawal, a "screw release mode" feature, which is a sub-mode of the dynamic compensation is intended as mitigation.However, upon review of the rcu logs, investigation indicated that the user stopped the dynamic compensation, which, by design, deactivated this feature.As a consequence, the root cause is traced to user error with a potential lack of training or understanding that holding the dynamic compensation might have helped.The user indicated that there was no negative impact to the patient outcome and no patient harm.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Issue #3: the analysis was conducted by tpm team.Log analysis confirmed the lateralized screws placement but infirmed the allegation of screw release mode causing a screw to be lateral to plan.The investigation showed that the correct log file was identified.The investigation showed that excessive force was exerted on the driver all along the screw placement, with a maximum of 3mm of deviation measured by the device.Moreover, during navigation, excessive force warnings were displayed, and the screw trajectory display was lateral to plan, consistently with the assessed screw placement.There was no indication of device malfunction.Based on the investigation findings, no corrective and/or preventive action is proposed.The user indicated that there was no negative impact to the patient outcome and no patient harm.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Root cause: issue #2: issue is traced to user error, due to not using the screw release mode.Issue #3: based on the review, the most probable cause is a use error.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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: 23534235
• Report Number: 1526439-2025-01487
• Device Sequence Number: 21379117
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Physician
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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