NA 1806-0113Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540196026), received between Sep 4, 2015 and Feb 29, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Break; Fracture; Difficult to Remove; Break; Fracture; Difficult to Remove

  AS REPORTED: "DURING NAIL REMOVAL, THE TIP OF THE UNIVERSAL ROD WAS BROKEN, AND THE TIP OF THE UNIVERSAL ROD BECAME FILLED IN THE PROXIMAL PORTION OF THE NAIL, MAKING REMOVAL IMPOSSIBLE."

  Patient problems: Foreign Body In Patient

  MAUDE report 18811044 ↗
• InjuryApr 14, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "UNIVERSAL ROD BROKE AT THE CONNECTION WHEN EXTRACTING A T2 HUMERAL NAIL THAT WAS INSERTED ABOUT 10 YEARS AGO. BECAUSE A NEW FRACTURE OCCURRED DISTAL TO THE NAIL, IT WAS DECIDED TO TREAT WITH A PLATE, AND THE NAIL WAS EXTRACTED THIS TIME. THE NAIL COULD NOT BE REMOVED DUE TO BREAKAGE OF THE UNIVERSAL ROD, SO ANOTHER ATTEMPT IS MADE TO REMOVE THE NAIL ON THE (B)(6) 2022."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116135 ↗
• MalfunctionApr 13, 2021Fracture; Fracture

  AS REPORTED: "THE EVENT OCCURRED DURING PROXIMAL UPPER ARM FRACTURE INTRAMEDULLARY NAIL REMOVAL. WHEN REMOVING THE NAIL WHICH WAS IMPLANTED ABOUT 2 YEARS AGO, THE THREADED PART OF THE UNIVERSAL ROD WAS BROKEN AND THE NAIL COULD NOT BE REMOVED. THE TIP OF THE REMOVER (PROBABLY THE UNIVERSAL ROD) STUCK WITH THE NAIL AND CLOSED WITH THE TIP LEFT ON THE NAIL, AS THEY COULD NOT BE REMOVED."

  Patient problems: Foreign Body In Patient

  MAUDE report 11655842 ↗
• MalfunctionFeb 17, 2020Fracture; Fracture

  AS REPORTED: "WHEN THE T2H NAIL WAS ATTEMPTED TO REMOVED, AND EXTRACTION ROD, CONICAL T2 HUMERUS AND UNIVERSAL ROD, SHORT T2 HUMERUS WERE CONNECTED, THE CONNECTION PART (TIP PART) OF UNIVERSAL ROD, SHORT T2 HUMERUS WAS BROKEN. THE OPERATION WAS CONTINUED AND COMPLETED WITHOUT PROBLEM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9718015 ↗
• MalfunctionSep 4, 2015Bent; Break

  IT WAS REPORTED BY THE REP THAT WHEN EXTRACTING A STAPLE THE EXTRACTOR BENT 90 DEGREES AND SNAPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5055954 ↗