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

Catalog Number	451570101
Medical Device Problem Codes	Device Alarm System (1012); Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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 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 1.8mm inaccuracy of the anterior chamfer cut an-3.2mm inaccuracy of the posterior cut.The investigation found that there is some array movement during full planning step.As array movement may have occurred prior to any femur or tibia cuts, there is a potential risk of inaccurate bone resections.The investigation found that there was also some array movement during first tibia cut step.When bone array moves, the accuracy of the system compromised, and this could lead to inaccurate cuts.The investigation found that the verify check point was done before femur and tibia cuts began and was within system threshold limits, but after all the femur cuts and tibia cuts completed, verify checkpoint was not done, so array movement could not be confirmed.The most probable root cause of the reported issue of 2 cuts with 1-2mm variance is the combination of potential array movement, sub-optimal leg positioning, leg/robot movement, and sub-optimal landmark acquisition.The root cause for those factors could not be determined.Device history 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.
Event or Problem Description
It was reported that during a total knee arthroscopy (tka) surgical procedure, while using the robotic assisted satellite station device, robotic assisted base station device, and the robotic assisted saw handpiece device to make cuts, it was observed that 2 cuts had a 1-2mm variance.It was reported that the surgeon tried progressing to another cut, however the system gave excessive distal plane movement errors.It is unknown if the robot was mounted to the surgical bed.It was reported that manual tools were used to continue the procedure.During review of the device event log it was found that there was approximately a 1.8mm inaccuracy of the anterior chamfer cut and 3.2mm inaccuracy of the posterior cut.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: 24638807
• Report Number: 1818910-2026-05009
• Device Sequence Number: 18682031
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: (01)10603295519492
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• 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: 01/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown