TRIGEN 71751129Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010515414), received between Apr 5, 2021 and Jan 23, 2025 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THE SET UP FOR A TRAUMA CASE, THE HUMERAL NAIL DRILL GUIDE WAS NOT SITTING CORRECTLY WITH THE JIG. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MINUTES, WITH A COMPETITOR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217707 ↗
• InjuryFeb 20, 2023Break

  IT WAS REPORTED THAT DURING SURGERY THE GUIDE¿S PRONGS/TEETH THAT HOLD THE HUMERAL NAIL DRILL GUIDE BROKE OFF. ONE BROKEN PIECE ENTERED THE SURGICAL SITE AND REQUIRED AN UNPLANNED IRRIGATION AND SUCTION TO REMOVE IT. AFTER THIS PROCEDURE, THE BROKEN PART WAS NOT SEEN ON X-RAY. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY AND THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406358 ↗
• MalfunctionApr 18, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT A NAIL PROX DROP WAS NOT FUNCTIONING PROPERLY; THE TARGET BAR WAS NOT ACCURATELY SUFFICIENT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683484 ↗
• InjuryApr 5, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY A HO LOAN KIT WAS USED AND SEVERAL INCONVENIENT WERE NOTICED. THE SURESHOT HUMERAL DRILL GUIDE PROBE FAILED. THE PROXIMAL JIG WAS FAULTY CAUSING ALL OF THE PROXIMAL SCREWS TO MISS THE NAIL. ALL SCREWS ENDED UP BEING DONE BY HAND MAKING PERFECT CIRCLES WITH BOTH DISTAL SCREWS AND PROXIMAL SCREWS. IT WAS REPORTED A SIGNIFICANT THE CASE ENDED UP DELAYED FOR OVER 2 HOURS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616781 ↗

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