MAUDE Adverse Event Report: DEPUY IRELAND VELYS SATELLITE STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570101
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.H11 additional narrative: investigation summary the investigation could confirm the reported issue of "the tibia cut was 3mm distal to expected plan.They are requesting the log files to be downloaded and reviewed." the issue was investigated and reviewed by the systems team.The investigation could confirm the reported issue as the pointer tool was utilized to verify tibial resection plane.The pointer tool was utilized to verify tibial cut plane, which showed approximately -3.0 mm inaccurate cut in the distal part of the tibia.This confirms the user reported issue.The investigation found that the most probable root cause of the reported issue is potential array movement of the tibia and sub-optimal leg positioning in combination with leg/robot movement.The investigation found that the tibia array may have been bumped or moved slightly at the start of the tibia cut the checkpoint was completed just prior to the tibia cut, so array movement was unlikely at the start of the cut, however the array was not checked at the end of the cut so array movement cannot be confirmed.While the exact cause of the array movement cannot be established, array movement is generally caused by the arrays not being securely attached.The investigation found that during most of the tibia cuts, the leg was sub optimally placed with a flexion of ~118 degrees to 137 degrees of flexion.This may have contributed to the leg moving during operation, which could lead to inaccurate cuts or saw blade deflection.There were no defects found with the system or software.The software was performing as intended.The user indicated that there was no negative impact to the patient outcome and no patient harm and the investigation indicates that the system was behaving properly.The investigation found that the most probable root cause of the reported issue is sub-optimal leg positioning in combination with leg/robot movement and sub-optimal landmark acquisition.The root cause for those issues could not be determined.Additionally, it was found that the user didn't mount the robot to the bedrail which can be considered improper handling.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review due to positive service history, dhr review only covers the related service records.Service history record review result is not relevant to the current complaint.
Event or Problem Description
It was reported that during a total knee arthroscopy (tka) surgical procedure, while using the robotic assisted satellite station device and the robotic assisted base station device it was observed that the tibia cut was 3mm distal to expected plan.It was reported that there was nothing unordinary during the procedure.It was reported that the robot was not mounted to the surgical bed.There were no reported adverse consequences to the patient.No additional information could be provided.

• Brand Name: VELYS SATELLITE STATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24703689
• Report Number: 1818910-2026-05326
• Device Sequence Number: 10467604
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: (01)10603295519492
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K202769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• 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: 451570101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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