T2 1828-0928SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540200259), received between Sep 12, 2018 and Jan 14, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2020Fracture; Fracture

  IT WAS REPORTED: PRIMARY T2 FEMORAL RETROGRADE SURGERY WAS PERFORMED ON (B)(6) 2017. APPROX. 2 MONTHS AFTER THE SURGERY, THE NAIL BREAKAGE AT THE PROXIMAL SCREW HOLE WAS FOUND. ON (B)(6) 2019, A FRACTURE AT THE SITE OF THE NAIL BREAKAGE WAS SUSPECTED. A REVISION SURGERY WAS NOT PLANNED AT PRESENT.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 9587677 ↗
• InjurySep 12, 2018Break

  T2 FEMORAL NAIL WAS RETROGRADE INSERTED INTO THE CASE WITH TUMOR. ON (B)(6) 2018, THE NAIL BROKE IN THE PROXIMAL PART. ON (B)(6) 2018, THE BROKEN PART WAS REMAINED IN THE PATIENT, THE NAIL WAS REMOVED AND FIXED WITH A PLATE BY REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 7870740 ↗