TriLeap Lower Extremity Anatomic Plating System 3.5 mm Ti Variable Angle Screw Length 14 mm, Dark PurpleRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810112594836), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionSep 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A MTP FUSION CASE USING THE TRILEAP SET THE FIRST ISSUE WAS WITH THE CUP/ CONE REAMERS, THE REAMERS NOT BEING SHARP ENOUGH. THE SURGEON USED SIX DIFFERENT REAMERS AND SAID ALL WERE DULL AND NOT CUTTING AWAY AT THE BONE LIKE THEY SHOULD BE. THE SURGEON WAS ASKED IF HE FELT LIKE HIS POWER WAS HIGH ENOUGH AND HE ASSURED THAT IT WAS. AFTER TRYING THESE MULTIPLE TIMES, THE DOCTOR HAD TO THEN MANUALLY REMOVE THE BONE AT THE JOINT WITH A RONGUER. THE SIZE CUP REAMERS USED IN THE CASE WERE 22,20, AND 18. THE SIZE CONE REAMERS USED IN THE CASE WERE 18,16,14. NEXT, THE ISSUE WAS WITH THE MOST MEDIAL DISTAL HOLE DEALT WITH MULTIPLE LOCKING SCREWS NOT LOCKING INTO THE PLATE. WHEN PLACING THE PLATE THREADED OLIVE WIRES WERE USED TO EVENTUALLY USE COMPRESSION FORCEPS TO GAIN AXIAL COMPRESSION. NEXT STEP, A COAXIAL DRILL GUIDE SCREWED INTO THE PLATE WAS USED TO DRILL FOR THE DISTAL MEDIAL SCREW. THEN A 2.7 DRILL BIT WAS USED TO DRILL AND MEASURED FOR A 14MM LOCKING SCREW OFF OF THE DRILL BIT. WHEN PUTTING THE SCREW IN BY HAND THE SURGEON COMPLAINED THAT THE SCREW WAS NOT LOCKING INTO THE PLATE. TROUBLESHOOTING WAS TRIED BY TRYING ANOTHER 14MM LOCKING AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236276 ↗