TriLeap Lower Extremity Anatomic Plating System Small Ratchet Handle w/ Quick CouplingRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810112592726), received between Nov 12, 2024 and Oct 16, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT STERILE PROCESSING DEPARTMENTS STATES THE DEVICES WERE WARPED OR BROKEN. NO PATIENT INVOLVEMENT OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23314138 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED IN AN UNKNOWN DATE, THE INSTRUMENT BROKE DURING SPD. THE EVENT OCCURRED DURING STERILE PROCESSING, FIELD INSPECTION AND DURING CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755096 ↗
• MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ORIF OF A FEMUR, A DHS 6H WAS USED AND THE PLATE DID NOT SEAT ON THE T HANDLE DHS INSERTER. UNSURE WHAT WAS WRONG WITH PLATE. TSP WAS USED AND THE SM HEXAGONAL PELVIC SCRDRIVER/LRG HNDL WAS USED TO BEND THE PLATE AND THE SHAFT ENDED UP BENDING AS WELL. TWO OF THE DEVICES WERE BENT. THE CABLES WERE USED AND THE CABLE LOCK WOULD NOT LOCK. ALSO, THE RATCHETING DRIVER HAD A 3.5 HEX STUCK AND UNABLE TO TAKE OUT. THERE WAS NO PATIENT CONSEQUENCE. IT WAS FURTHER REPORTED THAT THE COUPLING MECHANISM USED WERE THE JEWELERS CAP HANDLE WITH QUICK COUPLING AND THE SMALL RATCHET HANDLE WITH QUICK COUPLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101986 ↗
• MalfunctionNov 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ORIF OF A FEMUR, A DHS 6H WAS USED AND THE PLATE DID NOT SEAT ON THE T HANDLE DHS INSERTER. UNSURE WHAT WAS WRONG WITH PLATE. TSP WAS USED AND THE SD314.001 WAS USED TO BEND THE PLATE AND THE SHAFT ENDED UP BENDING AS WELL. TWO OF THE DEVICES WERE BENT. THE CABLES WERE USED AND THE CABLE LOCK WOULD NOT LOCK. ALSO, THE RATCHETING DRIVER HAD A 3.5 HEX STUCK AND UNABLE TO TAKE OUT. THERE WAS NO PATIENT STATUS, OUTCOME, OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668973 ↗