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	05/14/2025
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 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
It was reported that during a velys uka case, the surgeon detected that the femoral array moved prior to making any resections on the femur.The tibial resections were not affected and were performed using the system.The surgeon was informed that they could bail to manual instrumented uka using the intuition instruments, but the surgeon wanted to complete the case using the velys system.Due to the array motion, the surgeon restarted the software and used the intuition kit tibial spacer block in order to reacquire the tibial landmarks.Because the femur was intact, they were able to reacquire those landmarks on intact anatomy.The surgeon completed the femoral resections without issue using this technique.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information received, ¿it was reported to me that during a velys uka case on 5/14, the surgeon detected that the femoral array moved prior to making any resections on the femur.The tibial resections were not affected and were performed using the system.The surgeon was informed that they could bail to manual instrumented uka using the intuition instruments, but the surgeon wanted to complete the case using the velys system.Due to the array motion, the surgeon restarted the software and used the intuition kit tibial spacer block in order to reacquire the tibial landmarks.Because the femur was intact, they were able to reacquire those landmarks on intact anatomy.The surgeon completed the femoral resections without issue using this technique¿.The velys array set knee was not returned to medtech orthopaedics for evaluation.However, the investigation performed by the systems team on the involved velys base station (pi-17473607642502340) found evidence that the femur array moved during the tibial cut step.While the exact cause of the potential array movement cannot be established, array movement is generally caused by the arrays not being securely attached.Therefore, it is recommended to ensure that the array is properly secured during the procedure to avoid array movement; refer the "instrumentation" section of the ifu (090260192 rev.D) for the assembly steps of the bone arrays.Additionally, it is mention on the ifu that adjustments are not permitted after the first bone resection; if movement of the bone array occurs, the reference frame becomes inaccurate, and the robotic-assisted procedure must be aborted.The procedure should then be completed using conventional manual instruments, as indicated to the surgeon after the reported event.A manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.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 j&j medtech orthopaedics 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: 22202550
• Report Number: 1818910-2025-09670
• Device Sequence Number: 20763989
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: (01)10603295520146
• Combination Product (Y/N): N
• 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): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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