TRIGEN 71674077Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03596010560735), received between Nov 20, 2019 and Feb 18, 2026 — classified as 8 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT, DURING RETOGRADE METAFEMUR INTRAMEDULLARY NAIL SURGERY, THREE (3) REDUCER BROKE UPON INSERTION INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376982 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, WHEN USING THE REDUCER, THE THREAD BROKE OFF. THE PIECE FELL INSIDE THE PATIENT AND WAS REMOVED FROM THE CANAL, WITH THE HELP OF STRONG TWEEZERS. THE PROCEDURE WAS COMPLETED, AFTER A NON SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821759 ↗
• MalfunctionAug 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE REDUCER FRACTURED. NO FRAGMENTS WERE DEPOSITED IN THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A GUIDE INSTEAD OF THE REPORTED DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22767939 ↗
• MalfunctionAug 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE REDUCER CONNECTOR OF ONE (1) REDUCER BROKE OFF. NO PIECES FELL INTO THE PATIENT, AND ALL THE BROKEN PIECES WERE ACCOUNTED FOR. THE PROCEDURE RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906857 ↗
• MalfunctionJul 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A FEMUR FRACTURE REDUCTION, ONE REDUCER BROKE. IT WAS COMPLETELY REMOVED FROM THE PATIENT, AND ANOTHER SURGICAL TECHNIQUE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347726 ↗
• MalfunctionFeb 3, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT, DURING USE, WHILE BACKSLAPPING THE DEVICE TRYING TO GET IT OFF THE PATIENT, THE REDUCER GOT LODGED TOGETHER AND IT CHIPPED OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16297789 ↗
• MalfunctionJan 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN IM NAILING PROCEDURE, THE REDUCER TOOL BROKE AT THE INSTRUMENT JUNCTION INSIDE THE PATIENTS' FEMUR. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135492 ↗
• MalfunctionAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, WHILE ASSEMBLING A REDUCER DURING SURGERY, THE SLOT ORIENTATION PIECE BROKE INTO PIECES. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316329 ↗
• MalfunctionJul 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A TRIGEN REDUCER BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080789 ↗
• InjuryOct 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGICAL PROCEDURE, A REDUCER BROKE. THIS HAPPENED INSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. IT IS UNKNOWN IF THIS CAUSED A DELAY OR NOT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710021 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A TRIGEN REDUCER BROKE, NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507496 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE REDUCER THREADS WERE SEEN TO BE DAMAGED. AS THIS WAS NOTICED DURING FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806697 ↗
• MalfunctionApr 22, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, A REDUCER BROKE DURING USE OUTSIDE OF THE PATIENT. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710972 ↗
• MalfunctionApr 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE T-HANDLE IS STUCK TO THE REDUCER. INSTRUMENTS OUTSIDE PATIENT, SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. PROCEDURE FINISHED WITH COMPETITOR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683495 ↗
• MalfunctionApr 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE DEVICE BROKE WHILE IN USE AFTER HITTING BY A HUMMER. NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617569 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT A PIECE OF THE REDUCER HAD BROKEN OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484356 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED THAT, A PIECE OF THE REDUCER HAS BROKEN OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391220 ↗
• InjuryFeb 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY THE REDUCER WAS BEING USED AS PER IT'S INDICATION. WHEN ATTEMPTING TO REMOVE THE INSTRUMENT WITH A SLOTTED MALLET, THE THREADS OF THE CONNECTION BROKE OFF INSIDE OF THE PATIENT, LEAVING THE REDUCER STUCK INSIDE THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED WITH A LESS THAN OR EQUAL TO 30 MINS DELAY USING A COMPETITOR DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284589 ↗
• InjuryFeb 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, REDUCER DEVICE BROKE WHERE IT SCREWS TOGETHER. THE DEVICE BROKE DURING SURGERY, WHILE INSIDE THE PATIENT. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283630 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT THE REDUCER BROKE DURING CASE OUTSIDE OF PATIENT. S+N BACKUP AVAILABLE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086983 ↗
• InjuryDec 23, 2020Break; Incomplete or Inadequate Connection; Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN ASSEMBLING THE SLOT ORIENTATION ON TO THE REDUCER, THE BLACK COLLAR/ SLEEVE DISENGAGED. THE INNER-PIECE INSIDE THE SLOT ORIENTATION BROKE OFF AND THE PIECE WAS NOT USABLE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. IT WAS REPORTED THAT THE PROCEDURE WAS FINISHED WITH A CHANGE IN THE SURGICAL TECHNIQUE. IT IS UNKNOWN WHAT THE CHANGE WAS IN THE PROCEDURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066631 ↗
• InjuryNov 26, 2020Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL NAIL PROCEDURE THE REDUCER BROKE WHILE PUTTING INTO PATIENT'S CANAL. A DELAY OF LESS THAN 30 MIN WAS REPORTED. A S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910942 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE DURING SURGERY. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. A S&N BACKUP WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10663314 ↗
• MalfunctionSep 17, 2020Break; Break

  IT WAS REPORTED THAT REDUCER BROKE OUTSIDE THE PATIENT DURING AN UNSPECIFIED SURGERY THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. NO INJURY REPORTED. NO PATIENT HARM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551795 ↗
• InjuryJun 24, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT IN A REVISION SURGERY, WHEN ASSEMBLING THE INSTRUMENT OVER THE GUIDEWIRE WHEN ADVANCING THE BLACK COLLAR ON THE STAR ORIENTATION DISENGAGED, WHICH CAUSES THAT THE PRODUCT BE UNSTABLE. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. THE PROCEDURE WAS ENDED WITH A CHANGE IN THE SURGICAL TECHNIQUE.

  Patient problems: Injury

  MAUDE report 10188107 ↗

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