MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW INTERFACE RIGHT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570106
Medical Device Problem Codes	Device Slipped (1584); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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: investigation summary = > the velys saw interface right was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that the right-sasi exhibits an overall appearance of moderate wear consistent with multiple uses in a clinical setting.No other defects that could have contribute to the reported issue were observed.Functional evaluation was conducted using a saw wing fixture.The assessment found the right-sasi saw clamp lever was free to articulate without the saw wing fixture engaged.However, while conducting functional tests with the fixture attached, the assessment found undesired movement or play between the sasi clamp and sasi itself.Additionally, it was noted that minimal force was required to open the saw clamp lever while the saw wing fixture was engaged.The connection issues between the sasi and saw handpiece are known product issues.Based on the investigation findings, the root cause of the undesired movement or play between the sasi clamp and sasi itself is traced to design.The product issue has been addressed through depuy synthes quality management system.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 a total knee arthroscopy (tka) surgical procedure it was observed that an error message popped up on the velys unit.It was reported that handpiece and velys saw interface right (sasi) were switched out and the case continued.During in-house engineering evaluation it was determined that there was undesired movement or play between the sasi clamp and sasi itself.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: VELYS SAW INTERFACE RIGHT
• 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: 24889076
• Report Number: 1818910-2026-06934
• Device Sequence Number: 18604729
• Product Code: OLO
• UDI-Device Identifier: 10603295519478
• UDI-Public: (01)10603295519478(10)J46580
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• 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: 451570106
• Device Lot Number: J46580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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