T2 1845-0928SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540412379), received between Sep 18, 2020 and Sep 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2020Fracture; Fracture

  AS REPORTED: "AFTER TREATMENT OF THE RIGHT FEMORAL INTRAMEDULLARY NAIL, THE PATIENT APPEARED TO BE A NON-UNION. FIRST, RE-FRACTURE WAS PERFORMED NEAR THE DISTAL SCREW HOLE. THE DOCTOR WAS WATCHING THE PLACE BECAUSE THERE WAS AN INTRAMEDULLARY NAIL. NEXT, THE INTRAMEDULLARY NAIL WAS BROKEN IN THE VICINITY." ADDITIONAL INFORMATION: "THE PATIENT REMAINED A NON-UNION AND DID NOT HAVE BONE FUSION." "THE PATIENT FELT UNCOMFORTABLE AS HE WENT DOWN THE STAIRS ON JULY 31ST. AFTER THAT, HE VISITED THE HOSPITAL AND TOOK AN X-RAY, WHICH CONFIRMED A FRACTURE IN THE DISTAL PART OF THE FEMUR AND A BROKEN NAIL." THE BROKEN NAIL WAS REVISED WITH A T2 ALPHA GT NAIL.

  Patient problems: Discomfort; Failure of Implant; Limb Fracture; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10554812 ↗