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

Catalog Number	451570105
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during evaluation of the device, it was determined that the robotic assisted saw interface device was loose.It was initially reported that the anterior chamfer, anterior and tibia for surgeon was 1-2mm over resection for each cut.This event did not occur during surgery.There was no patient involvement.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the velys saw interface left was returned for evaluation.Visual analysis of the left-sasi device revealed no significant damage or visual defects that could have contributed to the reported event.The device shows moderate wear, which is consistent with multiple uses in a clinical setting.A functional evaluation was performed using the saw wing fixture.The assessment found that the left-sasi saw clamp lever articulated freely without the saw wing fixture engaged.However, during functional testing with the fixture attached, undesired movement or play was observed between the sasi clamp and the sasi itself.Additionally, it was noted that minimal force was required to open the saw clamp lever while the saw wing fixture was engaged.Based on the investigation findings, the root cause of the undesired movement or play between the sasi clamp and sasi itself is due to a design issue and has been escalated to a capa.

• Brand Name: VELYS SAW INTERFACE LEFT
• 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: 24489579
• Report Number: 1818910-2026-03918
• Device Sequence Number: 17388406
• Product Code: OLO
• UDI-Device Identifier: 10603295519461
• UDI-Public: (01)10603295519461(10)J46976
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 451570105
• Device Lot Number: J46976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown