T2 1830-0725SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540201317), received between Oct 30, 2024 and Dec 20, 2024 — classified as 1 injury, 1 malfunction.

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 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.

• InjuryDec 20, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED, T2 HUMERAL NAIL BROKE AFTER PRIMARY SURGERY ON (B)(6), INTRAOPERATIVE X RAYS WERE TAKEN ON (B)(6) WITH MINIMAL SIGN OF FRACTURE BUT WHEN PATIENT WAS MONITORED ON (B)(6) FRACTURE WAS EVIDENT. THE IMPLANT WAS REMOVED FROM THE PATIENT AND WAS ELIMINATED.

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

  MAUDE report 20995679 ↗
• MalfunctionOct 30, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "NAIL BREAKS WHEN PLACED IN THE NAIL INSERTION SPACE". ADDITIONAL INFORMATION RECEIVED 10/17/24; IT WAS A PRIMARY SURGERY. SURGEON DRILLED THE CANAL, PUT A HUMERUS NAIL, AND WHEN ADJUSTING THE COMPRESSION SCREW, HE LEANED 2.7 SCREWDRIVER ON THE PROXIMAL PART OF THE NAIL AND THE NAIL MATERIAL BECAME DEFORMED. NAIL HAD TO BE REMOVED AND ANOTHER ONE WITH SAME MEASURES WAS REPLACED. THERE WAS NO DEBRIS, ONLY MATERIAL FATIGUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571068 ↗