NA 464.40SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982232366), received between Dec 13, 2017 and Dec 13, 2017 — classified as 1 injury.

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

• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A FEMORAL NAIL IN 2004 DURING AN UNKNOWN PROCEDURE. POST-OPERATIVELY, PATIENT WOULD RETURN TO SURGERY FOR A PLANNED REMOVAL OF THE FEMORAL NAIL FOR A TOTAL HIP. DURING THE PLANNED EXPLANATION ON (B)(6) 2017, THE PATIENT HAD AN INTERTROCHANTERIC FRACTURE. THE INTACT FEMORAL NAIL AND UNKNOWN NUMBER OF SCREWS WERE REMOVED. A 2-HOLE DYNAMIC HIP SYSTEM (DHS) WAS IMPLANTED WITH A LAG SCREW AND TWO (2) CORTICAL SCREWS FOR THE FRACTURE. THERE WAS A ONE (1) HOUR SURGICAL DELAY DUE TO DIFFICULTY GETTING THE NAIL OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS WAS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) 9MM TI SOLID FEMORAL NAIL 400MM-STERILE. (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7113916 ↗