MAUDE Adverse Event Report: DePuy Ireland VELYS; Orthopedic Stereotaxic Instrument

Catalog Number	451570101
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total knee arthroplasty (tka) surgical procedure, when using the robotic assisted satellite station device and the robotic assisted base station device it was observed that the flexion gaps (medial distal condyle) was not lining up with what the surgeon was seeing and feeling in the patient anatomy.After re-registering, they went back into the accubalance graph, went through the range of motion with the knee, and the flexion gaps increased medially and laterally.They went through the range of motion three more times, and the surgeon was still not seeing satisfactory measurements.They then re-registered points, remeasured the center of the tibia, posterior/distal condyle, and anterior aspect of femur.The surgeon then proceeded back to the accubalance graph and was able to get measurements that lined up with the patient¿s anatomy.After this, they moved forward to resections and made them with machine size 9 settings, but they noticed the trial did not meet resections.It was reported that the size 9 was much larger than the resections.The surgeon then chose the size 8 trial for a better fit.The posterior chamfer was too deep however, and the patient anatomy was not making contact with the posterior chamfer in the trial, so they used an 8 femur with cementing and not a press fitting (they were not planning on using cementing for this case).The surgeon also did make a second tibial cut as well, trialed, and cemented.Per the surgeon, the outcome was satisfactory, even though it was not the ideal plan.It was reported that the robot was not mounted to the surgical bed.It was reported that the procedure was delayed due to re-registering five times.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.No further information was 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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

• Brand Name: VELYS
• 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 ; +1(908)386-3534
• MDR Report Key: 50913635
• Report Number: 1818910-2026-16657
• Device Sequence Number: 12094812
• Product Code: OLO
• UDI-Device Identifier: 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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• 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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2025
• 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