T2 1806-1005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540196545), received between Mar 27, 2020 and May 6, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2021Failure to Align; Material Deformation; Misassembled During Installation; Failure to Align; Material Deformation; Misassembled During Installation

  AS REPORTED: "T2 FEMORAL NAILS ARE USED IN A TEMPORARY OPERATION ON THE 11TH. USES LONG-TERM HOSPITAL EQUIPMENT. THE SCREW PART OF THE REPORTED PART WAS DEFORMED AND THE DEVICE WAS NOT FIXED FIRMLY. INSERT 3 SCREWS PROXIMALLY USING A DEVICE. CONFIRM THAT ONE OF THE MOST RECENT SCREWS DEVIATES FROM THE SCREW HOLE. THE OPERATION ENDS AS IT IS. NO WITNESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785673 ↗
• MalfunctionMay 11, 2020Failure to Align; Failure to Align

  ON THURSDAY, APRIL 9, 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; No Known Impact Or Consequence To Patient

  MAUDE report 10045495 ↗
• MalfunctionMar 27, 2020Failure to Align; Failure to Align

  THE SURGEON REPORTED THAT DURING A T2 FEMORAL NAIL PROCEDURE, HE ATTACHED THE JIG AND THE PROXIMAL NAIL MISSED THE JIG. THE SURGEON COMPLETED THE CASE FREE HAND. THERE WAS A SUCCESSFUL OUTCOME BUT THIS RESULTED IN A DELAY OF 40 MINUTES THE SURGEON IS CONCERNED THAT THE JIG IS WOBBLY ON THE NAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9890950 ↗