NA 1806-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540196415), received between Jan 14, 2019 and Jul 22, 2020 — classified as 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2020Fracture; Fracture

  THE ITEM BROKE INTO TWO PARTS. REPLACEMENT WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10307946 ↗
• MalfunctionJan 14, 2019Break

  THE HOSPITAL REPORTED THE FOLLOWING EVENT: "MEASURER SHORT BROKEN, UNUSABLE." THE ADDITIONAL INFORMATION RECEIVED INDICATE THAT THE EVENT HAPPENED DURING AN INTERVENTION, REMOVAL OF A T2 NAIL. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243900 ↗