TRIGEN 71674009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010560490), received between May 20, 2021 and Jan 7, 2024 — classified as 1 injury, 1 malfunction.

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

• InjuryJan 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, X-RAYS SHOWED THAT A TOOTH FROM THE LAG SCREW TAP FRACTURED AND WAS IN THE PATIENT. THE BROKEN TOOTH WAS RETRIEVED FROM PATIENT DURING THE SAME SURGERY, USING A PAIR OF KOCHER AND HEMOSTAT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461340 ↗
• MalfunctionMay 20, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, IT WAS NOTICED THAT THE FOLLOWING INSTRUMENTS OF THE TRIGEN¿ INTERTAN¿ INSTRUMENT SET ARE WARPED DUE TO WEAR AND TEAR OVER PAST 3 YEARS: LAG SCREW DRILL SLEEVE (CASE-(B)(4)), INTERTAN 3.2MM GUIIDE PIN SLEEVE (CASE-(B)(4)), LAG SCREW TAP (CASE-(B)(4)), LAG SCREW DRIVER (CASE-(B)(4)), COMPRESSION SCREW HEXDRIVER (CASE-(B)(4)), SUBTROC LAG SCREW DRIVER (CASE-(B)(4)), 130 RAD DRILL GDE DROP (CASE-(B)(4)), UNKNOWN TRIGEN INSTRUMENT (CASE-(B)(4)), UNKNOWN TRIGEN INSTRUMENT (CASE-(B)(4)). THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS GREATER THAN 30-MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853760 ↗

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