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	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional 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
Problem reported: during cuts, posterior plane unreachable, then it was, then an error prevented cuts again.Array movement errors were present as well.Requesting fse to pull log files: was this an uka or tka procedure? tka.When was the issue observed? during surgery.What step were they on when this issue occurred? cuts.Troubleshooting: unk; no switch to manual tools necessary.If issue with cuts is reported, is robot mounted to the bed? unk.Patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? no.Are patient treatments delayed or cancelled? no.Next day of surgery: unk.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿during cuts, posterior plane unreachable, then it was, then an error prevented cuts again.Array movement errors were present as well.Requesting fse to pull log files.The velys array set knee was not returned to depuy synthes.However, the investigation performed by the systems team on the involved velys base station (b)(4) confirmed the reported issue.The investigation determined that array movement occurred during the femoral cutting steps.The femoral array checkpoint verification was performed only after all attempted femoral cuts had been completed, and the checkpoint values were outside the acceptable system threshold, confirming femoral array movement.The system relies on the precise positioning of both the bone and saw arrays to accurately track the anatomy and the saw blade location.Any movement of an array disrupts the system¿s reference to the bone or saw, resulting in altered or lost positional accuracy.Consequently, array movement can lead the system to misinterpret the true location of the bone or saw, which may prevent the saw blade from reaching the correct resection plane or may cause cuts to be performed in an unintended location while the exact cause of the array movement cannot be established, array movement is generally caused by the arrays not being securely attached.It is recommended that the user follow the guidance on ifu-090260022sw19 rev b pages 248 appendix 1: system troubleshooting: bone array moved during the procedure.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.Corrected: h3.

• 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: 24192819
• Report Number: 1818910-2026-01636
• Device Sequence Number: 7894290
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: (01)10603295520146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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