VELYS 4515-70-005Recalls & reported problems
Depuy (Ireland) · VELYS Robot-Assisted Solution ARRAY DRILL PIN 125 mm x 4 mm · Class 1
All models of VELYS (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295519096), received between Dec 16, 2025 and Jul 29, 2026 — classified as 3 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Limb Fracture3
- Osteopenia/ Osteoporosis2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the surgeon believes fracture of a distal femur may have been caused by bicortical VELYS array pins causing stress riser. He mentioned that he would plan to place pins more distal and unicortical as per VELYS RAS standard pin placement. One patient treated non operatively, one patient treated with retrograde nail.
Patient problems: Limb Fracture
MAUDE report 50071492 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Limb Fracture; Osteopenia/ Osteoporosis
MAUDE report 23818948 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Limb Fracture; Osteopenia/ Osteoporosis
MAUDE report 23818183 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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