T2 1825-1042SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540199546), received between Mar 29, 2021 and Mar 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2021Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT : "WHEN A T2 LONG FEMUR NAIL WAS PLACED, WHEN THE NAIL HOLDER WAS REMOVED DURING CLOSURE, IT WAS NOTICED THAT A "WIRE" CAME OUT OF THE NAIL, WHICH WAS CUT FLUSH WITH THE NAIL. THE OPERATORS DO NOT KNOW EXACTLY WHERE THE WIRE CAME FROM, THE ANCILLARY INSTRUMENTS AND REAMERS ARE INTACT; THEY THINK IT IS THE INTERNAL THREAD OF THE NAIL. THERE WERE NO IMMEDIATE CONSEQUENCES FOR THE PATIENT, BUT FUTURE REMOVAL OF THE NAIL MAY BE MORE DIFFICULT IF THE THREAD IS DAMAGED."

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586432 ↗