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

Catalog Number	451570011
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the case, when the surgeon was cutting the tibia transverse cut, the tracker moved; the problem was with the tracker insertion.The surgeon managed to finish the case correctly without switching to manual mode.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: corrected: d1, d2a, d4 (catalog).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information received, ¿it was reported that sales rep went to support the first uka case in spain at the hospital and during the first case, when the surgeon was cutting the tibia transverse cut, the tracker moved (the problem was with the tracker insertion).The surgeon managed to finish his case correctly without switching to manual mode¿.The velys array set knee was not returned to medtech orthopaedics; however photos were provided for review.See attachment "12_jun_2025_03_04_43_25476.Eml".Photographic review shows the assembly of the bone array with the array clamp; however, no visible defects were identified in the devices that could contribute to the reported "loose connection" condition.Additionally, functionality-related issues cannot be assessed through photographic analysis.Furthermore, as the involved "bone array" and "array clamp" were not returned for physical evaluation, it was not possible to conduct functional testing to replicate or verify the reported issue.Although the root cause cannot be confirmed with the available evidence, it is recommended to follow the validated assembly procedure to minimize the risk of improper engagement between the single-use array and its corresponding reusable instrument.For detailed instructions, refer to the instructions for use (ifu-09026019 rev.D), section "instrumentation ¿ assemble array to clamp" (pages 55¿56), which outlines the step-by-step process for correct assembly.The device lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.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 - the device lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: VELYS ARRAY SET KNEE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22372400
• Report Number: 1818910-2025-11000
• Device Sequence Number: 4463145
• Product Code: OLO
• UDI-Device Identifier: 10603295519072
• UDI-Public: (01)10603295519072
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 09/10/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/29/2025; 09/15/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown