TRIGEN 71674060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010560698), received between Jul 30, 2021 and Nov 10, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A TRIGEN ENTRY PORTAL TUBE BECAME LODGED IN HANDLE COUPLING AND BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF SURGERY WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791796 ↗
• InjuryJul 30, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, AN ENTRY PORTAL TUBE (CASE (B)(4)) WAS NOT ENGAGING IN A HANDLE. NO SIGNIFICANT SURGICAL DELAY OCCURRED, AND THE PROCEDURE WAS CONTINUED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO PATIENT INJURY WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250836 ↗

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