TRIGEN 71751108Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010515322), received between Sep 17, 2020 and Sep 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); they may or may not involve this specific model.

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 16, 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.

• MalfunctionSep 17, 2020Degraded; Degraded

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE THREADS ON BOLTS WERE STRIPPED. THERE WAS NO DELAY NOR INJURY REPORTED AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10546347 ↗
• MalfunctionSep 17, 2020Degraded; Degraded

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE THREADS ON BOLT WERE STRIPPED. THERE WAS NO DELAY NOR INJURY REPORTED AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10546324 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha