NA 1895-5060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540202154), received between Feb 1, 2022 and Feb 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "REVISION OF A RETROGRADE FEMORAL NAIL DUE TO A BROKEN CONDYLE BOLT. ALL COMPONENTS WERE REMOVED AND ANOTHER NAIL WAS IMPLANTED. SURGERY DATE (B)(6) /2022. ANOTHER RETROGRADE FEMORAL NAIL, WITH 2 SCREWS AND 2 BOLTS WERE IMPLANTED."

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419039 ↗