TRIGEN 71654505Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010585851), received between Dec 9, 2020 and Jan 18, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (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.

• MalfunctionJan 18, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION IT WAS FOUND THAT THE RUST IS BUILDING UP IN TWO DEVICES. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. RESULTS OF INVESTIGATION OF (B)(4) HAVE CONCLUDED THAT THIS UNIT WAS RUST WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11185585 ↗
• MalfunctionDec 9, 2020Corroded; Corroded

  IT WAS REPORTED THAT RUST S BUILDING UP INSIDE OF EXTENSION GUIDE BOLT. NO CASE INVOLVED AS THIS WAS FOUND DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978841 ↗

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