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

Catalog Number	451570107
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During in-house engineering evaluation, it was determined that the robotic-assisted solution array clamp device was chipped/shaved/delaminated.It was initially reported that the array clamp was not tightening properly, and the rubber washer of the clamp was damaged.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
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, 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: investigation summary the product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the velys array clamp has the rubber washer shredded off and was severely deformed.Shredded and deformation observed are consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assemblance; or by assembling the device in a misaligned position.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.Please review the velys¿ robotic-assisted solution for total knee surgical technique - femur first approach, and instructions for use (ifu) which indicates the proper handling and care process for the velys array clamp.Functional testing was conducted using the returned velys array clamp set and a product with the equivalent diameter of a velys fixation pin.The wedge component of the array clan bone assembly was able to be fully tightened through the wedge wingnut.The device was able to retain the pin as intended.The wing knob component that connects the two pieces together was able to be fully tightened and the teeth meshed as intended.The wing knob component that tightens onto the pins can be fully tightened both with and without pins inserted.The array clamp array clasp assy button was fully functional in securing, retaining, and releasing the production equivalent velys arrays (product code: 451570011) without difficulty.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the velys array clamp would have contributed to the complained issue.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.

• Brand Name: VELYS ARRAY CLAMP
• 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: 24757205
• Report Number: 1818910-2026-05661
• Device Sequence Number: 15737765
• Product Code: OLO
• UDI-Device Identifier: 10603295519379
• UDI-Public: (01)10603295519379(10)J45389
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K202769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 451570107
• Device Lot Number: J45389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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