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

Catalog Number	451611000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported the robot ran into the post of the patient array near the clamp during a posterior spinal fusion - pediatric.The camera had to be positioned in the anesthesia area making it hard to keep the patient sterile as well as capture the arrays.The issue was with the robot.They were sending robot to trajectory.Troubleshooting: had to get a new spin.While sending to a new trajectory the robot came close to hitting the patient array again however, they stopped the robot manually and manipulated the arm out of the field.They were able to send the robot to the trajectory again and it worked.Surgery was delayed 10 minutes.No patient consequence.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: g4 [pma/ 510(k)].H3, h6: investigation summary: according to the information received, the issue with the following product: 451611000 sn: (b)(6) was experienced: robot ran into the post of the patient array near the clamp.The camera had to be positioned in the anesthesia area making it hard to keep the patient sterile as well as capture the arrays.Results received from the engineering team: investigation summary: this complaint was found to have two issues : issue #1 - robot ran into the post of the patient array near the clamp.Issue #2 - the camera had to be positioned in the anesthesia area making it hard to keep the patient sterile as well as capture the arrays.Issue #1 - robot ran into the post of the patient array near the clamp.The investigation confirmed "robot ran into the post of the patient array near the clamp." however, the tool holder ran into the connector of the patient array (not the post).The investigation was conducted by the hw and sw team.The investigation showed the patient array exclusion zones were not violated by the software and the software functioned as intended.In the current technical solution, the exclusion zones are defined based on the position of the spheres of the patient array that do not enable to check specific zones of in the 3d space linked to the patient array like the connector.The system responded appropriately to the collision, the arm was stopped and the user was notified via pop-up of the collision.Based on the investigation, an assessment in the quality system for a design improvement has been opened.The user indicated that there was no negative impact to the patient outcome and no patient harm.Issue #2 - the camera had to be positioned in the anesthesia area making it hard to keep the patient sterile as well as capture the arrays.The investigation did not confirm "making it hard to keep the patient sterile".The investigation confirmed "the camera had to be positioned in the anesthesia area making it hard to capture the arrays".The investigation was conducted by the hw and sw team.The investigation showed the user did not follow the ifu or setup recommendation for thoraco-lumbar screw placement, which led to conflicts between the anesthesia area and camera station.(ifu page 114 where the position for thorocolumbar cases is recommended to be at the feet).Based on the investigation the most probable root cause for the issue can be tied to user error.The user indicated that there was no negative impact to the patient outcome and no patient harm.Root cause: issue #1 - robot ran into the post of the patient array near the clamp.Based on the review and analysis of log files, the most probable cause of the reported issue is an inappropriate software design on the definition of the patient array exclusion zones.This software issue has been addressed in a non-conformance.Issue #2 - the camera had to be positioned in the anesthesia area making it hard to keep the patient sterile as well as capture the arrays.Based on the review and analysis of log files, the allegation of keeping the patient sterile was not confirmed.The most probable cause of the reported issue is a not most appropriate or setup for the given indication.Based on the investigation the most probable root cause for the issue can be tied to user error.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review (dhr): no manufacturing record evaluation required as the issue is software design related.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VELYS NAVIGATION 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: 22713239
• Report Number: 1526439-2025-00943
• Device Sequence Number: 9393496
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• 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

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: 451611000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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
• Patient Sex: Unknown