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	10/08/2025
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.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
Navigation camera was not able to visualize robotic arm due to the lack of an extra joint.- t8 screw had to be lateralized from original plan, original trajectory was medial to plan.- error message of data matrix cards were scanned.Sales rep confirms that the they had not be previously scanned.Rep was able to clear the message and use the same data matrix cards - logs in the system.- per sales rep, fse not required.What type of spine surgery was it? t3-t12 ais case was this nav only or with robot? robot what side was the robot on? patient right what step were they on when this issue occurred? troubleshooting: patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? no are patient treatments delayed or cancelled? no.
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: 451611000 sn (b)(6).When was the issue observed? (b)(6) 2025.Navigation camera was not able to visualize robotic arm due to the lack of an extra joint.T8 screw had to be lateralized from original plan, original trajectory was medial to plan.Error message of data matrix cards were scanned.Sales rep confirms that the they had not be previously scanned.Rep was able to clear the message and use the same data matrix cards.Investigation summary: issue #1: investigation done under velys camera station (b)(6).Issue #2: the r&d and tpm teams investigated the issue of t8 left screw being medial.The log file was reviewed and it was observed that the screw was placed via freehand navigation, while burring, drilling and taping was executed in robotic-assisted mode.Lateral force due to soft tissue could have been a cause, however there is no data to confirm this hypothesis.The use of the driver in freehand navigation could have caused the user to misplace the screw, according to plan, because of a very tight anatomy.The last driver placement observed in the log indicate a medial deviation.However, without any data on the post-operative screw placement, it is impossible to state on the accuracy of the displayed images.As such, root cause remains unknown.The user reported that there was no adverse effect on the patient¿s outcome, and no further medical intervention was needed.No defect was found in the system or software.This issue will be continued to be monitored through complaint trending as part of post market surveillance activities.Issue #3: the software development team investigated the issue of the error message of data matrix cards were scanned.The log file was reviewed and showed the same smart card being scanned twice within 600ms.This pop-up message displayed when scanning the smartcards was confirmed.The software appropriately handled the second scan with a pop-up for the user to confirm.It is suspected that when the card was inserted in the scanning area, it was left in the area and detected twice by the scanner.This resulted in the software asking confirmation to the user whether to use the most recent instrument array #5 data, or the already scanned one: the software responded appropriately to the situation and the user was able to proceed.No defect found in the system or software.Complaints will continue to be monitored.Root cause: issue #2: device behaved as intended.Root because that could be tied to user cannot be confirmed.Issue #3: device behaved as intended.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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 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 ; chemin blanc 38; le locle ; SZ ; 9083863534
• MDR Report Key: 23543374
• Report Number: 1526439-2025-01494
• Device Sequence Number: 21262244
• 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: 451611000
• 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: 12/18/2025
• Initial Report FDA Received Date: 11/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VELYS CAMERA STATION; VELYS ROBOTIC-ASSIST STATION
• Patient Sex: Unknown