TRIGEN 71654554Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010650382), received between Dec 20, 2019 and Aug 12, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, ONE (1) CANNULATED IMPACTOR - SHORT WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION REVEALED THAT THE THREADED TIP OF THE CANNULATED IMPACTOR - SHORT HAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966770 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (1) CANNULATED IMPACTOR - SHORT SHEARED OFF UPON REMOVAL FROM A SEMIEXTENDED DRILL GUIDE. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO PATIENT HARM WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249670 ↗
• MalfunctionSep 3, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY, ONE (X1) CANNULATED IMPACTOR SHORT BROKE DURING MALLET STRIKE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY BY CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675067 ↗
• InjuryJul 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING META NAIL CASE, THE THREADED END OF THE CANNULATED IMPACTOR - SHORT BROKE INSIDE OF PATIENT, ALL PIECES WHERE RECOVERED. 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 12236063 ↗
• MalfunctionMay 6, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AFTER PROCEDURE, IT WAS FOUND THAT THE CANNULATED IMPACTOR - SHORT AND THE CANNULATED IMPACTOR- MED WERE FUSED TOGETHER AND WILL NOT COME APART. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784521 ↗
• MalfunctionMar 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE CANNULATED IMPACTOR - SHORT SHEERED OFF IN THE DRILL GUILD. IT IS UNKNOWN WHEN IT HAPPENED. IT WAS DISCOVERED DURING A TRAINING SESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541009 ↗
• InjuryAug 7, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE CANNULATED IMPACTOR - SHORT BROKE WHILE IMPACTING A TIBIA NAIL. THIS HAPPENED DURING USE INSIDE THE PATIENT. NO DELAY TO PROCEDURE. A S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. ANY OTHER ISSUE THAT COULD AFFECT THE PATIENT'S CONDITION WAS NOT REPORTED BY THIS EVENT. INFORMATION WAS REVIEWED.

  Patient problems: No Information

  MAUDE report 10382526 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SHORT IMPACTOR TIP BROKE OFF. ALL PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504501 ↗

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