T2 1818-1220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540673350), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionFeb 21, 2025Difficult to Insert; Difficult to Insert

  AS REPORTED: "THE END USER HAS REPORTED THAT AN ISSUE HAS OCCURRED DURING THE T2 ANKLE FUSION SURGERY PERFORMED. AFTER SUCCESSFULLY PLACING THE DYNAMIC COMPRESSION SCREWS AND PROXIMAL STATIC SCREWS, THEY ENCOUNTERED A PROBLEM WHILE ATTEMPTING TO PLACE THE POSTERIOR CALCANEUS SCREWS. THE DRILL WAS UNABLE TO PASS THROUGH THE NAIL AND INSTEAD HIT THE NAIL, NOT GOING THROUGH THE DEDICATED HOLE AS INTENDED. THE SURGEON WAS UNABLE TO GENERATE PROPER COMPRESSION TO ENHANCE THE FUSION PROCEDURE, WHICH SIGNIFICANTLY IMPACTED THE OUTCOME OF THE SURGERY. DUE TO THE DEFECT, THE SURGEON HAD TO FREEHANDEDLY INSERT THE SCREW, WHICH CAUSED A SIGNIFICANT DELAY AND INCONVENIENCE, AFFECTING THE OVERALL OPERATING TIME".

  Patient problems: Insufficient Information

  MAUDE report 21437927 ↗