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

Catalog Number	451611001
Medical Device Problem Codes	Break (1069); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Problem reported: t2-l3 open fusion procedure.Two issues identified during the case: 1.There are small cracks on the leds on the portion of the handgrip closest to the tool interface.2.The camera doesn't have enough articulation so it makes it difficult to navigate during surgery.When placing the thoracic pedicle, the robot was going to hit the patient¿s head.Surgeon intervened and stopped the robot.Surgeon attempted to manually manipulate the robot arm out of the way but it would return back to the original spot near the patient.Case was completed nav only.What step were they on when this issue occurred? throughout.Was this a robotic or navigation only procedure? robotic.Troubleshooting: none.Patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? no.Are patient treatments delayed or cancelled? no.
Additional Manufacturer Narrative
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.
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: 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: h3, h6: investigation summary: according to the information received, the issue with the following product: 451611001 (b)(6).Problem reported: t2-l3 open fusion procedure.Two issues identified during the case: 1.There are small cracks on the leds on the portion of the handgrip closest to the tool interface.2.The camera doesn't have enough articulation so it makes it difficult to navigate during surgery.Investigation summary: issue 1: there are small cracks on the leds on the portion of the handgrip closest to the tool interface.Issue 2: the camera doesn't have enough articulation so it makes it difficult to navigate during surgery.Investigation results under velys camera station pi-17589173285209270.Issue 1: the velys spine r&d hardware team conducted an investigation into the allegation of deformation of the protective glass part on the distal cone of the handgrip component, which make up the led light trackers.The investigation confirmed the allegation of atypical appearance of the protective glass on the led lights through review of pictures shared and follow-up with the field service engineer.The investigation shows that the cause for this abnormal appearance came from manufacturing.The final appearance of each protective glass is currently not inspected, in manufacturing.However, based on the investigation findings, no subsequent impact were found other than cosmetic, and the handgrip was found to be functional and accurate as expected.Non-conformance was opened to document complete supplier investigation, corrections and risk assessment for the manufacturing cause.No defects were found with the software.The user indicated no harm to patient.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Root cause: based on the review of picture, measurement of part lots, and manufacturing controls, root cause is traced to manufacturing.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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 33410
• Manufacturer Contact: elba bello ; chemin-blanc 38; le locle ; SZ ; 9083863534
• MDR Report Key: 23294186
• Report Number: 1526439-2025-01307
• Device Sequence Number: 14668401
• Product Code: OLO
• UDI-Device Identifier: 10705034646008
• UDI-Public: (01)10705034646008
• 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: 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: 09/23/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 11/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/30/2025; 11/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VELYS CAMERA STATION.; VELYS NAVIGATION STATION.
• Patient Sex: Unknown