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

Catalog Number	451570011
Medical Device Problem Codes	Unintended Movement (3026); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that patient underwent unicompartmental knee arthroplasty (uka) on (b)(6) 2025.When performing the distal cut of the femur, the surgeon was not able to complete the cut with the robot due to a conflict between femur array and saw.There was a loss of visibility plus some physical conflict.The surgeon focused on putting the pins at 45 degree or lower, but the array itself was put high not in alignment with the femur.The surgeon was still able to do the majority of the cut with the robot and completed the most internal part of the cut (closest to the knee center) manually.The final leg alignment did match the plan and the surgeon was satisfied with the clinical result.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information received, ¿when performing the distal cut of the femur, the surgeon was not able to complete the cut with the robot due to a conflict between femur array and saw.There was a loss of visibility + some physical conflict.He focused on putting the pins at 45 degree or lower, but the array itself was put high not in alignment with the femur.See attached photo for position of pins and arrays.He was still able to do the majority of the cut with the robot and completed the most internal part of the cut (closest to the knee center) manually.The final leg alignment did match the plan and the surgeon was satisfied with the clinical result.¿ the velys array set knee was not returned to medtech orthopaedics; however, photos were provided for review.See attachment "16_jun_2025_10_05_20_25954.Eml".The review of the photographic evidence revealed that the orientation of the array drill pins securing the array bone appears to be too close to the saw line.This positioning may lead to interference with the saw handpiece during resection and could potentially result in unintentional contact with the femur array, contributing to the reported condition of "loss of visibility and physical conflict." furthermore, the reported event can be corroborated, as the as the complaint reporter (jnj robotics software senior manager) was present during the surgical procedure.Following the case, the complaint reported discussed the issue with the surgeon to assess and improve the positioning of the array drill pins and the orientation of the bone array to prevent similar issues.For detailed instructions and recommendations, please refer to the instructions for use (ifu-09026019 rev.D), section "intraoperative use ¿ bone array setup" (pages 116¿119), which outlines the step-by-step process for proper location and orientation of the involves instruments.A manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.The overall complaint was confirmed as the observed condition of the bone array setup would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to user error, and 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 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: 22386658
• Report Number: 1818910-2025-11213
• Device Sequence Number: 13030593
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: (01)10603295520146
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,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: 06/16/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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