T2 ALPHA 2341-1127SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327290493), received between Apr 19, 2023 and Nov 6, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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 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.

• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE PREOPERATIVE PLAN WAS TO USE A 360MM NAIL, BUT THE SURGEON WAS INSTRUCTED TO PRODUCE A 270MM NAIL DURING THE SURGERY, SO THE 270MM NAIL WAS OPENED AND PREPARED. HOWEVER, THE SURGEON'S UNDERSTANDING WAS THAT THE NAIL WAS 370MM, AND THE NAIL WAS INSERTED DEEPLY WITH A HAMMER TO THE PATIENT TIBIA. THIS LED TO THE ANTERIOR PART OF THE TIBIA AND THE CARTILAGE WERE SCRAPED. +15MM END CAP WAS INSERTED TO THE NAIL AND THE BONE DEFECTS WERE FILLED WITH ARTIFICIAL BONE. DAMAGE OF THE ANTERIOR TIBIA AND CARTILAGE".

  Patient problems: Limb Fracture

  MAUDE report 18073287 ↗
• MalfunctionApr 19, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "DURING TIBIAL NAIL INSERTION, THE DRILL SLEEVE WAS NOT REMOVED AND THE NAIL WAS INSERTED. THE DRILL SLEEVE AND THE NAIL WERE STUCK, SO THE NAIL WAS REPLACED WITH A DIFFERENT SIZE AND SURGERY RESUMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773498 ↗