TRIGEN 71674558Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556363393), received between Mar 4, 2021 and Aug 5, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT ONE (1) LAG SCREW LENGTH GAUGE WASN'T MEASURING CORRECTLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710850 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE WRENCH OF A LAG SCREW LENGTH GAUGE AND THE CAPTURE OF A MEDIUM HEXDRIVER WERE CHIPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE AND A SCREW WAS REMOVED WITHOUT CAPTURE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875430 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT ONE (1) LAG SCREW LENGTH GAUGE WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 18826935 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE LAG SCREW LENGTH GAUGE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392390 ↗
• MalfunctionJan 31, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LAG SCREW LENGTH GAUGE WAS NOTICED TO BE CHIPPED DURING CLEANING BY SPD STAFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13403754 ↗
• MalfunctionJan 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE BLADE OF A LAG SCREW LENGTH GAUGE BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED, OR FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267713 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, ONE OF THE PRONGS THAT PUSHES UP AGAINST LAG SCREW LENGTH GAUGE SNAPPED OFF. DEVICE OUTSIDE THE 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 13171012 ↗
• MalfunctionJan 4, 2022Flaked; Material Twisted/Bent; Naturally Worn; Flaked; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT A LAG SCREW LENGTH GAUGE IS WORN, FADED, CHIPPED AND BENT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154525 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE LAG SCREW LENGTH GAUGE BROKE OUTSIDE OF THE PATIENT. THERE WAS NO DELAYS AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816841 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE LAG SCREW LENGTH GAUGE (CASE-2021-00040944-1) AND THE SURESHOT HEXDRIVER (B)(4) WERE NOTICED BROKEN. THE DEVICES BROKE OUTSIDE THE PATIENT. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408833 ↗

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