TRIGEN 71631026Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010604910), received between Sep 12, 2018 and May 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING SURGERY, THE TIPS OF ONE (1) 4MM TROCAR DRILL SLEEVE BROKE OFF, AND A 4.0 DRILL WAS COLD WELDED INTO THE TROCAR. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068013 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) 4MM TROCAR DRILL SLEEVE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS ANY DELAY. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749217 ↗
• MalfunctionNov 23, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A 4MM TROCAR DRILL SLEEVE IS JAMMING . AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865719 ↗
• MalfunctionSep 12, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE INSTRUMENTATION INTRA-OPERATIVELY FAILED TO ALIGN PROXIMAL FEMORAL IMPLANTS.

  Patient problems: No Information

  MAUDE report 7870810 ↗

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