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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total knee arthroplasty procedure the checkpoints were significantly off-plan by 4-5 mm, leading to the procedure being switched to manual mode after unsuccessful re-registration attempts.The arrays reportedly did not move, and the surgery was delayed but not cancelled.There were no reported injuries, medical interventions, or prolonged hospitalization.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿bailed to manual yesterday in the 1st case.The checkpoints were way off of plan by 4-5 mm.They re-registered with the same result.Reporter states that the arrays didn't move¿.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 (pi-(b)(4)) could confirm the reported issue.The investigation found that the most probable root cause of the reported issue is due to array movement.The root cause for array movement could not be determined.No defect was found with the system.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 lot: an evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.

• 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 33410
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23967608
• Report Number: 1818910-2026-00136
• Device Sequence Number: 11994139
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: (01)10603295520146
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Distributor
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/06/2026
• 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