TriLeap Lower Extremity Anatomic Plating System 22MM Cannulated Cone ReamerRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810112592306), received between Sep 17, 2024 and Mar 13, 2026 — classified as 3 malfunctions.

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

• MalfunctionMar 13, 2026Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE NOT SHARP AND TAKES A LOT TO REAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591054 ↗
• MalfunctionMar 12, 2026Failure to Cut

  IT WAS REPORTED ON AN UNKNOWN DATE THE REAMERS INSIDE THE TRILEAP SET WERE NOT SHARP AND TOOK A LOT TO REAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582628 ↗
• MalfunctionSep 17, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2024, WHILE USING THE INSTRUMENTS, SURGEON REPORTED THAT THE REAMERS WERE NOT SHARP. THIS IS A BRAND NEW TRILEAP SET AND HAVE NOT BEEN USED PREVIOUSLY. THE REAMERS WERE USED IN SURGERY BUT DID NOT AFFECT THE OUTCOME OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238489 ↗