TRIGEN 71654525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010644602), received between Mar 15, 2022 and Jun 11, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SEMIEXTENDED GUIDE BOLT BROKE INSIDE NAIL WHEN SURGEON CROSS THREADED JIG INTO TIBIA NAIL. IT IS UNKNOWN IF ANY PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671132 ↗
• MalfunctionMar 15, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE SEMIEXTENDED GUIDE BOLT WAS FIXED IN THE NAIL THROUGH THE GUIDE BUT WHEN IT SHOULD BE REMOVED, IT WAS STOCKED IN THE NAIL AND THERE WAS NO POSSIBILITY TO REMOVE IT. THE THREADED PROXIMAL PART IN THE NAIL DID LOOK GOOD SO NO HARM WAS CAUSED. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO THE PATIENT. A SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776130 ↗

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