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

Catalog Number	451570011
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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.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.Investigation summary 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 could confirm the reported issue.The investigation found that the most probable root cause of the reported issue is the combination of user did not follow proper/recommended technique to acquire landmarks and did not maintain contact between the pointer tip and bone surface during acquisition, sub-optimal leg position, and potential array movement.The investigation also found that there was significant array movement during tibia fiducial acquisition before starting any other landmark acquisition.Movement of the array compromises the reference frame, leading to inaccurate registration of anatomical landmarks.All acquired landmarks may become invalid, as their spatial relationship to the bone is no longer reliable.The array must be re-stabilized, and all tibial landmark acquisitions¿including the tibia checkpoint¿must be repeated to restore accuracy.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 to ensure the array is properly secured during the procedure to avoid array movement.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history the device lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that velys base station, velys satellite station, and velys array set knee were involved in an event during a total knee arthroplasty procedure.The reported issue was that, in the final landmarking stage after anterior cortex, the system prompted the user to repeat tibia landmarking for all points.This resulted in a surgery delay of approximately 5 minutes, with the action taken being re-landmarking.The procedure was successfully completed, and there was no negative impact or harm to the patient.The complaint devices were available for review, and no fragments were generated during the event.

• 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 Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24363504
• Report Number: 1818910-2026-03057
• Device Sequence Number: 9888642
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: (01)10603295520146
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 451570011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/17/2026
• 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