TRIGEN 71751133Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010515445), received between Aug 3, 2020 and Feb 17, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, TWO (2) HUMERAL NAIL IMPACTORS BROKE WHILE TRYING TO REMOVE A NAIL FROM A HUMERUS. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366603 ↗
• MalfunctionNov 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE THREAD OF ONE (1) HUMERAL NAIL IMPACTOR FRACTURED INSIDE ONE (1) STRAIGHT NAIL GUIDE BOLT WHILE IMPACTING. NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645570 ↗
• MalfunctionApr 24, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN ONE (1) HUMERAL NAIL IMPACTOR WAS ATTACHED TO THE NAIL FIXATION SCREW, IT DID NOT FULLY ENGAGE. THE DOCTOR RETROIMPACTED THE NAIL, RESULTING IN THE THREAD BREAKING, LEAVING PART OF IT INSIDE THE FIXATION SCREW. THE BROKEN PART WAS REMOVED AND THE NAIL WAS IMPLANTED WITH THE SAME IMPACT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900923 ↗
• MalfunctionApr 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A OSTEOSYNTHESIS PROCEDURE, UPON IMPACTION ONE (1) HUMERAL NAIL IMPACTOR BROKE AT THE THREADED PART AND REMAINED INSIDE THE COUPLING SCREW OF THE NAIL. NO BROKEN PIECE ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY PASSING THE NAIL MANUALLY. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183693 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, THE PROXIMAL PIECE OF THE HUMERAL NAIL IMPACTOR DETACHED IN RETRO IMPACT. ADDITIONALLY, THE DRILL BITS WERE IN POOR CONDITION. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN, CHANGING SURGICAL TECHNIQUE. PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156136 ↗
• MalfunctionJan 3, 2022Crack; Unintended Movement; Crack; Unintended Movement

  IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS NOTICED THAT THE HUMERAL NAIL IMPACTOR WAS SEEN TO BE CRACKED AT THE WELD AND TURNS FREELY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13146243 ↗
• MalfunctionNov 22, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, AFTER A HUMERAL NAILING SURGERY, IT APPEARED THAT THE END OF THE HUMERAL NAIL IMPACTOR WAS STUCK IN THE STRAIGHT NAIL GUIDE BOLT. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12855931 ↗
• InjuryJan 13, 2021Break; Solder Joint Fracture; Break; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, A HUMERAL NAIL IMPACTOR BROKE WHILE INSTALLING THE NAIL. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY REPORTED. NO HARM OR INJURY REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165668 ↗
• InjuryAug 3, 2020Break; Break

  IT WAS REPORTED THAT THE HUMERAL NAIL IMPACTOR END BROKE OFF DURING IMPACTION. NO DELAY. A S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10360100 ↗

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