TRIGEN 71653030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010548160), received between Jun 5, 2020 and Dec 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE META RETRO FEM NAIL 10 X 30 BECAME STUCK IN THE PROXIMAL FEMUR BONE UPON IMPACT. WHILE ATTEMPTING TO REMOVE IT FOR FURTHER MILLING, THE IMPACT ON THE GUIDE CAUSED IT TO BREAK AT THE SCREW THREAD. FINALLY, IT WAS REMOVED BY IMPACTING IT IN THE OPPOSITE DIRECTION WITH PRESSURE PLIERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR'S DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802785 ↗
• InjuryJun 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A REVISION SURGERY TO REMOVE TRIGEN RETROGRADE FEMORAL NAIL (INITIAL INSERTION DATE (B)(6) 2019, REVISION SURGERY DATE (B)(6) 2020) THE THREADS OF THE 2 PROXIMAL INTERNAL HEX CAPTURE SCREWS DISASSEMBLED DURING REMOVAL AND FURTHERMORE FELL INTO THE MEDULLARY CANAL. THE SURGEON HAD A HARD TIME TO REMOVE THEM AND THE SURGERY WAS DELAYED BY MORE THAN 30 MINS. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Injury

  MAUDE report 10122902 ↗