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

Catalog Number	451570105
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
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: the velys saw interface left was returned to depuy synthes for evaluation.Visual analysis found the weld of one of the two pins interfacing with the saw lever was fractured, however the device remained one piece.The overall appearance of the device showed signs of normal wear from multiple uses in a clinical setting.Functional testing of the sasi revealed the saw clamp lever component was jammed/seized with no movement, preventing the device from being assembled and disassembled as intended.Gulling is suspected to have occurred internally between the lever pins and the lever component causing the metal components to fuse together.Once this occurred it is likely that further attempts to open and close the lever would apply additional torque between the weld and the pin cause the weld to break.Per the instruction for use, it is indicated under sections: point of use care, containment and transportation, and preparation before cleaning for all reusable instruments, all moving parts must be thoroughly cleaned and lubricated after each use to avoid buildup of debris within the articulating components of the device.It is suspected proper lubrication/cleaning was not performed with the device.There is no indication that a design or manufacturing issue has caused the complaint condition.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 saw interface left would contribute to the complained device issue.Based on the investigation findings, the potential cause of the functionally stiff condition of the saw clamp component is traced to improper device maintenance and no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused or contributed to the 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.
Event or Problem Description
It was reported that during service and evaluation, it was determined that saw lever on the robotic assisted saw interface (sasi) device was fractured.It was noted in the service order that the device was frozen during set-up.A spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• Brand Name: VELYS
• 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: 24746376
• Report Number: 1818910-2026-05551
• Device Sequence Number: 9318856
• Product Code: OLO
• UDI-Device Identifier: 10603295519461
• UDI-Public: (01)10603295519461(10)PC5932773
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 451570105
• Device Lot Number: PC5932773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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