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

Catalog Number	451570101
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
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 distal cut was rather thin.It was reported that the surgeon did not make the cut and bailed to manual devices.It was reported that the robot was mounted to the surgical bed.During review of the device event log, it was found that there was approximately 1.6mm inaccuracy in the distal cut.It was reported that there was a delay in the procedure due to the event.There were no reported adverse consequences to the patient.No additional information could be provided.
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: the actual device was evaluated.The device log files were reviewed for this event, and the investigation found that the complaint of inaccurate cuts could be confirmed since the pointer tool was used to verify resection planes.The investigation found that there was approximately 1.6mm inaccuracy in the distal cut.The investigation found that in the log file analyzed, significant array movement occurred during multiple steps before beginning of femur or tibia cuts.As array movement may have occurred prior to any femur or tibia cuts, there is a potential risk of inaccurate bone resections.When bone array moves, the accuracy of the system compromised, and this could lead to inaccurate cuts.There are no defects found with the system or software.The software was performing as intended.The investigation found that the most probable root cause of the reported issue is sub-optimal leg positioning and leg/robot movement in combination with potential array movement and sub-optimal anterior cortex line acquisition.The root cause for those issues could not be determined.

• 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: 24652486
• Report Number: 1818910-2026-05078
• Device Sequence Number: 6088051
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: (01)10603295519492
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown