T2 1822-1133SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540198037), received between Dec 2, 2019 and Dec 30, 2020 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionDec 30, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: "T2 TIBIA NAIL UNABLE TO BE DISCONNECTED FROM NAIL ADAPTER.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098175 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ALLERGIC REACTION, SKIN REDNESS 10 WEEKS POST SURGERY.

  Patient problems: Irritation; Reaction

  MAUDE report 9522106 ↗
• MalfunctionDec 2, 2019Material Erosion; Material Erosion

  CUSTOMER REPORTED TO OUR SALES REP DIFFICULTIES WHEN SCREWING THE NAIL ONTO THE TIBIAL TARGET DEVICE. IMMEDIATE STOP OF SCREWING AND CHECKING OF THE THREAD - ABNORMAL PRESENCE OF FILINGS/DEBRIS IN THE NAIL THREAD. ADDITIONALLY REPORTED: THE PROCEDURE WAS AN OSTEOSYNTHESIS OF A LEG FRACTURE THE EVENT HAPPENED BEFORE THE PROCEDURE : WHILE THE MATERIAL WAS BEING PREPARED : THE INCIDENT OCCURRED, SO THEY TOOK ANOTHER NAIL TO PROCEED NO PATIENT INVOLVEMENT BECAUSE IT HAPPENED JUST BEFORE THE SURGERY, THEY DID NOT TRIED TO INSTALL THE DEFECTIVE NAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9395264 ↗