MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS ARRAY DRILL PIN 125X4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	451570005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Limb Fracture (4518)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a light osteoporosis suffered a femoral fracture 2.5 weeks after a total knee arthroplasty procedure performed with the velys robotic assisted surgery system; the fracture occurred when she stood up from a seated position, and the surgeon suspected it was caused by the holes made by the velys array pins.All available information has been disclosed.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d6b, d10 (concomitant).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿postop (2.5 weeks) femoral fracture after vras tka procedure.Female patient, light osteoporosis.The fracture occurred when patient stood up from a seated position 2.5 weeks post op.And surgeon thinks this is due to the holes of the velys array pins¿.The velys array drill pin 125x4 mm was not returned to depuy synthes, however photos were provided for review.The radiographic images show a supracondylar periprosthetic fracture.However, due to the image quality and the limited evidence provided, it is not possible to assess the patient¿s bone density or determine the precise locations where the array drill pin were inserted during the procedure.Nonetheless, it is reasonable to suspect that the observed fracture may have occurred at or near the insertion sites.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.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 ARRAY DRILL PIN 125X4 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 23818183
• Report Number: 1818910-2025-21990
• Device Sequence Number: 18668076
• Product Code: LXH
• UDI-Device Identifier: 10603295519096
• UDI-Public: (01)10603295519096
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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: 451570005
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 03/02/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/13/2026; 03/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN KNEE FEMORAL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female