MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS SAW BLADE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	451570000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Popliteal arteria injury while using velys during a knee arthroplasty.The surgeon explained that they did not use retractors as usual for a recut and faced a popliteal arteria injury.They made a suture directly on the arteria to stop the bleeding and the patient had no major hemoragia, and no other vascular surgery needed.Artheriography was done.Procedure was completed successfully with a fifteen minute delay.Patient received surveillance in the icu for a night and a platelet-inhibiting agent.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information received, ¿the surgeon explained that he did not use retractors as usual for a recut and faced a popliteal arteria injury.He made a suture directly on the arteria and the patient had no major hemoragia, and no other vascular surgery needed¿.The velys saw blade was not returned to depuy synthes.However, with the available information it is know that the surgeon did not use the retractors during the resection process.According to the instructions for use (ifu-0902-60-022 rev.M), under the section performing resection, it states: ¿place retractors to protect soft tissues during the bone resections.The retractors must be placed so they can be held by the assistant without blocking the line of sight between the arrays and the camera.¿ additionally, under the section intraoperative use, the following cautions are mentioned: ¿there are no mechanical boundaries on the saw blade.Therefore, it must be controlled at all times by the surgeon.Prior to each resection, ensure the leg is stabilized in the desired position, and retractors are suitably placed.¿ and ¿incomplete retractor placement exposes soft tissues to potential damage.¿ 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.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: VELYS SAW BLADE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 23585660
• Report Number: 1818910-2025-20272
• Device Sequence Number: 9577565
• Product Code: OLO
• UDI-Device Identifier: 10603295519140
• UDI-Public: (01)10603295519140
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 451570000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown