MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 VELYS ARRAY SET KNEE; ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY

Catalog Number	451570011
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that velys base station, velys satellite station, and velys array set knee were involved in a reported event during a total knee arthroplasty procedure.The complaint described an issue with array movement, with the system exhibiting ongoing problems that prompted a request for field service engineer support to assist with troubleshooting.The event occurred intra-operatively, and there was no reported injury, medical intervention, or delay in patient treatment.No patient consequences or involvement were identified for any of the products.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿rep reported and issue with array movement during their case today.Rep stated the system has some "ongoing issues" and requested fse support to pull logs to help their team troubleshoot the root cause¿.The velys array set knee was not returned to depuy synthes.However, the log file review and investigation performed by the systems team on the involved velys base station (b)(4) confirmed the reported "array movement".The investigation found that during most of the attempted femur cuts and tibia cuts, there was considerable leg/robot movement.Additionally, the message "instruction: "[saw disabled] saw blade plane deviates too much from the cutting plane" displayed during all the cut steps.Excessive leg movement during cut steps could lead to potential significant array movement.The investigation also found that there is significant array movement during landmark acquisition steps as well as initial leg alignment and full planning steps also.The exact cause of the array movement cannot be determined in a log review.The potential faulty knee array set may have contributed as well as large leg movement during operation.The knee array set were requested to be returned for evaluation, but the request was not fulfilled by the user.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: VELYS ARRAY SET KNEE
• Common Device Name: ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24119180
• Report Number: 1818910-2026-01152
• Device Sequence Number: 6075875
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: (01)10603295520146
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 451570011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown