T2 1806-1007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327095449), received between Nov 19, 2020 and Sep 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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.

• MalfunctionSep 3, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHEN THE FEMORAL NAIL WAS LOCKED, A FALSE HOLE WAS DRILLED. THE NAIL WAS DIFFICULT TO DETACH FROM THE TARGETING DEVICE AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425610 ↗
• MalfunctionNov 19, 2020Failure to Align; Failure to Align

  ON (B)(6), AN ANTEGRADE T2 FEMUR INTRAMEDULLARY NAIL WAS PERFORMED ON A 17-YEAR-OLD BOY. (CONDITION AFTER FIXATOR SYSTEM). BOTH PROXIMAL LOCKING HOLES FAILED; THEY PASSED THE NAIL VENTRALLY. THE SURGEON PULLED THE NAIL OUT A BIT AND AGAIN BOTH LOCKING HOLES WENT PAST THE NAIL VENTRALLY DESPITE THE REPEATED TIGHTENING OF ALL SCREWS. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH TWO PROXIMAL FREEHAND BORES. SURGICAL DELAY OF 90 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10870173 ↗