EF1 DNE-6000-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810028397217), received between Mar 11, 2025 and Mar 11, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 11, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO POST-OP X-RAY SHOWED A BROKEN 5MM HALF PIN IN THE TIBIA. DOCTOR EXPLAINED THAT THE MOST PROXIMAL HALF PIN HAD BECOME DETACHED FROM THE FRAME AND THE PATIENT HAD SUBSEQUENTLY BROKEN THE MOST DISTAL TIBIAL HALF PIN. ALSO, SOME OF THE NUTS WERE ROUNDED AND CROSS THREADED. HE COMMENTED THAT THE METAL WAS TOO SOFT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 21579854 ↗