TRIGEN 71751135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010515469), received between Oct 8, 2020 and May 9, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE HEAD OF ONE (1) HUMERAL SMALL HAMMER BROKE OFF. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997396 ↗
• MalfunctionMay 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE HUMERAL SMALL HAMMER FRAGMENTED WHEN THE NAIL WAS BEING IMPACTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITORS DEVICE. EVEN THOUGH IT IS UNKNOWN IF BROKEN PIECES FELL INTO THE PATIENT, NO INJURY WAS REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264850 ↗
• InjuryOct 8, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE BEING USED, DEVICE BROKE INTO TWO PIECES OUTSIDE PATIENT. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM A COMPETITOR AND NO DELAY OR INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10648119 ↗

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