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

Catalog Number	451570106
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during a total knee arthroplasty (tka) surgical procedure, when using the robotic assisted saw interface device (sasi) right with the robotic assisted base station device it was noted the saw interface portion that clamps with the velys saw handpiece was loose despite being fully closed.It was reported that this may have contributed to error messages during the velys resections.It was reported that the robot was mounted to the surgical bed.It was reported that there was a 5-minute delay in the procedure due to the event.It was reported that the procedure was successfully completed.There were no fragments generated.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.No additional information could be provided.

• Brand Name: VELYS
• 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: 25143150
• Report Number: 1818910-2026-08568
• Device Sequence Number: 13113289
• Product Code: OLO
• UDI-Device Identifier: 10603295519478
• UDI-Public: (01)10603295519478(10)J46580
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2022
• 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