MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS ARRAY SET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent total knee arthroplasty (tka) on (b)(6), 2025.The surgeon had completed all of the femur cuts, and at the tibial cut, the position of the checkpoint was not accurate and they suspect the tibial array had moved.Remaining cuts were performed manually.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿1st case: the surgeon had completed all of the femur cuts and at the tibial cut, the position of the checkpoint was not accurate and they suspect the tibial array moved.Remaining cuts performed manually¿.The velys array set was not returned to medtech orthopaedics.However, the log file review and investigation performed by the systems team on the involved velys base station (b)(4) confirmed the reported issue.Per systems investigation on (b)(4), the log review found that on the posterior cut step there was atypical movement of the tibia array.However, during the event the tibia array was blocked from the cameras view, so the investigation cannot view the tibia array event.Based on the location of the tibia checkpoint and the position of where the user is trying to verify the checkpoint with the pointer tool, it aligns with the direction that the tibia center and ankle landmarks shifted after the tibia array event.Because of this the investigation can confirm that tibia array movement likely occurred.However, without getting the parts back for evaluation, damage or manufacturing defect could not be confirmed.Therefore, a potential cause for the reported issue cannot be established.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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22864040
• Report Number: 1818910-2025-14642
• Device Sequence Number: 18435589
• Product Code: OLO
• UDI-Device Identifier: 10603295519072
• UDI-Public: (01)10603295519072
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 451570001
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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