TRIGEN 71674066Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010560599), received between Feb 15, 2021 and Dec 1, 2022 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING USE, AN ALIGNMENT ARM BROKE WHILE ATTACHING TO THE JIG DURING THE NAIL PROCEDURE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895512 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT AN ALIGNMENT ARM IS BROKEN. AS THIS WAS NOTICED DURING FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628387 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) ALIGNMENT ARM ITEM BROKE IN HALF. IT BROKE DURING TRANSIT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538000 ↗
• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED THAT THEY NOTICED THE ALIGNMENT ARM WAS BROKEN AFTER USING IT DURING INTERTAN PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570915 ↗
• MalfunctionMar 31, 2022Crack; Crack

  IT WAS REPORTED THAT A ALIGNMENT ARM IS CRACKED. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961543 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861403 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT THE ALIGNMENT ARM IS BROKEN ON THE STEM, PROBABLY DUE TO CONSTANT STERILIZATION. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755176 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497218 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497185 ↗
• MalfunctionAug 16, 2021Crack; Crack

  IT WAS REPORTED, AN ALIGNMENT ARM WAS CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328825 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT, BEFORE AN INTERNAL FIXATION PROCEDURE, TWO (2) ALIGNMENT ARM DEVICES WERE FOUND BROKEN. THE PROCEDURE WAS COMPLETED USING 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 12166140 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT, BEFORE AN INTERNAL FIXATION PROCEDURE, TWO (2) ALIGNMENT ARM DEVICES WERE FOUND BROKEN. THE PROCEDURE WAS COMPLETED USING 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 12166111 ↗
• MalfunctionJul 8, 2021Crack; Crack

  IT WAS REPORTED THAT ONE (1) ALIGNMENT ARM WAS CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135470 ↗
• MalfunctionJun 18, 2021Break; Break

  IT WAS REPORTED THAT AN ALIGNMENT ARM BROKE OUTSIDE THE PATIENT DURING NAIL SURGERY. SURGERY WAS COMPLETED, BY USING A BACK-UP DEVICE WITHOUT DELAY, INJURIES NOR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022892 ↗
• MalfunctionApr 20, 2021Break; Break

  REF#(B)(4). IT WAS REPORTED THAT, THE DEVICES IN THE LIST WERE FOUND BROKEN OR CRACKED. THEY WERE USED BY CUSTOMER BEFORE DEFECT WAS FOUND IN THE WAREHOUSE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. CASE NUMBER/PART NUMBER/(B)(4) REF NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693179 ↗
• MalfunctionMar 12, 2021Crack; Crack

  IT WAS REPORTED THAT AN ALIGNMENT ARM WAS CRACKED. IT WAS DISCOVERED AFTER CLEANING WHEN IT WAS BEING REASSEMBLED. NO CASE REPORTED; THEREFORE, THERE WAS NO 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 11478029 ↗
• InjuryFeb 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SIDE OF THE ALIGNMENT ARM BROKE WHILE IN USE. THE ITEM WAS NOT NECESSARY TO COMPLETE THE SURGERY. A BACK UP DEVICE WAS AVAILABLE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. NOTHING FELL INTO THE PATIENT AND ALL THE PIECES WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326444 ↗

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