TriLeap Lower Extremity Anatomic Plating System 3.5 mm Ti Variable Angle Screw Length 16 mm, Dark PurpleRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810112594843), 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 PATIENT UNDERWENT A MTP FUSION CASE USING THE TRI-LEAP SET ON (B)(6) 2024. THERE WAS AN ISSUE WITH THE CUP AND 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. 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. THERE WAS AN ISSUE WITH THE MOST MEDIAL DISTAL PLATE HOLE. MULTIPLE LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. WHEN PLACING THE PLATE, THREADED OLIVE WIRES AND COMPRESSION FORCEPS WERE USED TO EVENTUALLY GAIN AXIAL COMPRESSION. 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. ANOTHER 14MM LOCKING SCREW WAS TRIED AS WELL AS A 16MM LOCKING SCREW BUT WITH NO LUCK. THE SUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236580 ↗