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

Catalog Number	451570011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that velys base station and velys array set knee were involved in a reported intra-operative event during a total knee arthroplasty.Following the anterior cortex acquisition, an alert indicated that the femoral checkpoint needed to be rechecked, prompting the surgical team to return to the femur and tibia checkpoints.Arrays were replaced, and the procedure continued without further issue.The event resulted in a delay to the surgery, but there were no reports of injury, medical intervention, or prolonged hospitalization, and no impact to the expected surgical outcome was indicated.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿2nd case.Problem reported: for 2 out of 3 cases on friday, following the anterior cortex acquisition, an alert popped up "femoral checkpoint needs to be rechecked" the software forced them to return to the femur and tibia checkpoints to complete.Replaced arrays and continued without issue.The velys array set knee was not returned to depuy synthes for evaluation.However, the reported issue was investigated and reviewed by the systems team on the involved velys base station (pi- (b)(6)).The investigation found during the log file review the following messages: 1.Tibia checkpoint is too close to medial and/or lateral plateau(s), or tibia checkpoint is too high.2.Femur checkpoint is too close to medial and/or lateral distal condyle(s), or femur checkpoint is too low or not anterior to posterior condyles.Based on the available information, the potential cause of the reported issue is related to user placement of the checkpoints on the arrays.As a result of placing the checkpoint on the arrays, the computation check is failing.The user can correct this issue by placing the femur and tibia checkpoints on the bone in the appropriate locations.The investigation found that both tibial fiducial landmark acquisition and femur fiducial landmark acquisitions are done sub-optimally.The check points were created on the pin/array and not on the bone.Since the checkpoints were placed on the pin/arrays, they lose their purpose and it would be difficult to confirm if there was femur array movement.When the checkpoint is placed on the pin/arrays, when array movement happens the checkpoint also moves.This may lead to failure in accurately diagnosing array motion during the procedure.Recommendations: it is recommended that the user follow the guidance on ifu 090260022sw19 rev b page 127 intraoperative use: bone checkpoints acquisition.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 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.

• 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: 24753996
• Report Number: 1818910-2026-05633
• Device Sequence Number: 16006251
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: (01)10603295520146
• 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
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/07/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown