Integra® Miltex® 40-225ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780436409), received between Mar 4, 2025 and Mar 4, 2025 — 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 4, 2025Break; Break

  A PHYSICIAN REPORTED THAT THE 4-1/2 DEL STR NAIL SPLITTER (40-225A) SNAPPED WHILE USING IT TO CUT PATIENT'S NAILS. THE FAILURE CAUSED A CUT TO THE PHYSICIAN'S HAND. THERE WAS AN UNSPECIFIED DELAY IN PROCEDURE AS THE USER HAD TO TREAT HIS HAND AND FIND ANOTHER INSTRUMENT. NO PATIENT INJURY OCCURRED.

  Patient problems: Laceration(s)

  MAUDE report 21521246 ↗