OSSIOfiber® Trimmable Fixation Nail System, Cannulated OF2054070SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290017630250), received between Jul 17, 2025 and Jul 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE DISTAL FEMUR, A K-WIRE PROVIDED WITHIN THE CONVENIENCE KIT BROKE DURING INSERTION INSIDE THE PATIENT'S BONE. THE BROKEN PART WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22529588 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE DISTAL FEMUR, A K-WIRE PROVIDED WITHIN THE CONVENIENCE KIT BROKE DURING INSERTION INSIDE THE PATIENT'S BONE. THE BROKEN PART WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22529587 ↗