NA 1806-5010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540196965), received between Dec 15, 2022 and Dec 15, 2022 — 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 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.

• MalfunctionDec 15, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DURING A T2 TIBAL NAIL PROCEDURE AND UNDER AMPLISCOPIC CONTROL, THE SURGEON PERFORMED THE BONE PERFORATION. THE TIP BROKE INSIDE THE BONE. A SECOND DRILL HAD TO BE USED, WHICH ALSO BROKE WITHIN THE BONE. A THIRD TIP WAS USED TO COMPLETE THE PROCEDURE. WITHIN THE PATIENT'S TIBIA, TWO TIP FRAGMENTS APPROXIMATELY 3-4 MM LONG REMAINED."

  Patient problems: Foreign Body In Patient

  MAUDE report 15993094 ↗
• MalfunctionDec 15, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DURING A T2 TIBIAL NAIL PROCEDURE AND UNDER AMPLISCOPIC CONTROL, THE SURGEON PERFORMED THE BONE PERFORATION. THE TIP BROKE INSIDE THE BONE. A SECOND DRILL HAD TO BE USED, WHICH ALSO BROKE WITHIN THE BONE. A THIRD TIP WAS USED TO COMPLETE THE PROCEDURE. WITHIN THE PATIENT'S TIBIA, TWO TIP FRAGMENTS APPROXIMATELY 3-4 MM LONG REMAINED."

  Patient problems: Foreign Body In Patient

  MAUDE report 15993093 ↗