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

Catalog Number	451611001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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.Additional narrative: investigation summary according to the information received, the issue with the following product: 451611001 sn (b)(6).1.During surgery loss camera connection - camera cord was plugged in the entire time - received error: connection was lost and then connection regained.This happened twice during the surgery.2.Rep stated the arm of the camera needs an extra joint to visualize the arrays.3.Robot never came into the field because they were unable to register the patient due to patient's high bmi.Could not capture the phantom array in the lateral scout.Results received from the engineering team: (uploaded under velys navigation station pi-(b)(4).Issue 1: investigation is under velys camera station pi- (b)(4): issue 2: investigation is under velys camera station pi-(b)(4).Investigation summary: issue 3: investigation was led by system and tpm team.Log were reviewed and investigated.The investigation confirms the allegation "they were unable to register the patient." the part of the allegation "[.] due to patient's high bmi [.]" is a reporter pre-supposed root cause.The investigation shows that only 7 of the 18 phantom fiducials were detected during the registration step (while 12 at minimum are required).Based on the available information there is insufficient evidence to determine a root cause conclusively.It is also important to note that all screw systems on label as compatible with velys spine are contraindicated for severe obesity.Velys spine itself is not contraindicated for obesity and relies on the contraindications of the implant and instrument families.As per (b)(4) fse noticed an issue where the robot arm contacted e-stop.Fse removed and repositioned arm.System is now performing as intended.The user indicated that there were no reports of injuries, medical intervention or prolonged hospitalization, even though the surgery was aborted.This issue will be continued to be monitored through complaint trending as part of post market surveillance.Root cause : issue 3: based on the available information, the patient size and anatomy plus the phantom size and location are greater than the allowable field of view from the imager, however there is insufficient evidence to determine this conclusively and therefore a root cause for this cannot be determined.It is also important to note that all screw systems on label as compatible with velys spine are contraindicated for severe obesity.Velys spine itself is not contraindicated for obesity and relies on the contraindications of the implant and instrument families.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history device history review for (b)(6).Manufacturing date: 29-oct-2025 the device has not been previously serviced.Device history record shows that sn: (b)(6) of (b)(6) was processed through the normal installation and inspection operations with no rework or nonconformities noted.Serial no: (b)(6) met all required criteria at the time of release with no issues documented during the installation process.Review of the device history record(s) showed that there were no issues during the installation 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.
Event or Problem Description
It was reported during thoracic percutaneous psf t8-t12 surgery, loss of camera connection occurred.Camera cord was plugged in the entire time.Received error: connection was lost and then connection regained.This happened twice during the surgery.Company representative stated the arm of the camera needs an extra joint to visualize the arrays.Robot never came into the field because they were unable to register the patient due to patient's high bmi.Could not capture the phantom array in the lateral scout.What step were they on when this issue occurred? registering arrays was this a robotic or navigation only procedure? robotic, robot was positioned on the patient's right side.Troubleshooting.Unknown patient involvement? yes were there reports of injuries, medical intervention or prolonged hospitalization? no are patient treatments delayed or canceled? yes, rep stated the surgery was aborted - no other surgeries are scheduled.Next day of surgery: none at this time rep requested for this to be escalated.All information has been disclosed.No further information was provided.

• 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: 24163308
• Report Number: 1526439-2026-00054
• Device Sequence Number: 9000695
• Product Code: OLO
• UDI-Device Identifier: 10705034646008
• UDI-Public: (01)10705034646008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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

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): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• 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