TriLeap Lower Extremity Anatomic Plating System Compression Wire 1.6mm for 3.0/3.5/4.0 Plates, Thread Length 20mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810112596168), received between Sep 22, 2026 and Sep 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 22, 2026Break; Material Deformation

  It was reported during an intra-operative procedure that COMP WIRE F/ 3.0/3.5/4.0 PL THREAD 20MM was used. While two 20 mm olive wires were being used to compress a TriLeap plate, one wire bent between the cone and the ball of the olive wire and then broke below the cone, flush with the bone. The surgeon changed the surgical plan and used two crossing screws instead. There was no reported patient harm, but the procedure was prolonged by 5 to 10 minutes. The allegation was limited to the wire, and the broken wire remained in the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858785 ↗