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

Catalog Number	451570101
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	03/10/2026
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during a total knee arthroplasty (tka) procedure, while using the robotic assisted satellite station device with the robotic assisted base station device, it was observed that the distal femur cut was good, but the anterior cut was off.It was reported that the procedure was completed manually.It was reported that the robot was not mounted to the surgical bed.There were no reports of injuries, medical intervention, or prolonged hospitalization.No further information was provided.
Event or Problem Description
Updated event description: it was reported that during a total knee arthroplasty (tka) procedure, while using the robotic assisted satellite station device with the robotic assisted base station device, it was observed that the distal femur cut was good, but the anterior cut was visually confirmed to be off, about 7mm more posterior than it should be.It was reported that it was so noticeably off to where the resections were completed manually.The surgeon moved to posterior cut to verify, and the saw blade was not cutting bone when it was supposed to cut 7mm.The surgeon downsized the femur from 5 to 4 with manual cutting blocks using angel wing as reference on anterior cut.Final trial numbers were way off.Cemented implants planned and used.
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: b5: during subsequent follow-up with the reporter, additional information was obtained.Therefore, the event description has been updated accordingly.

• 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: 24673740
• Report Number: 1818910-2026-05158
• Device Sequence Number: 13315752
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: (01)10603295519492
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 451570101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 05/07/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 03/31/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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