TRIGEN 71631451Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556399743), received between Nov 4, 2020 and Jan 30, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Mechanics Altered

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION (FEMUR FRACTURE IM NAIL) PROCEDURE, THE META-TAN DRILL GUIDE CONNECTION TO THE META TAN DROP WAS LOOSE AND WAS NOT A SNUG FIT. THIS MADE THE DROP UNSTABLE. THERE WAS A SURGICAL DELAY RETRYING TO TARGET THE JIG. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221004 ↗
• MalfunctionJun 30, 2025Off-Label Use; Difficult or Delayed Separation; Off-Label Use; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE NAIL ENGAGED WITH ONE (1) META-TAN DRILL GUIDE OFF, SO SURGEON HAD TO BURR OFF ONE (1) PERCUTANEOUS GUIDE BOLT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356710 ↗
• InjuryFeb 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SURGERY THE LAG SCREW MEASUREMENT WAS INCORRECT, INCORRECT SIZE LAG SCREW WAS SUBSEQUENTLY OPENED AND INSERTED. IT WAS THEN REMOVED AND A MORE APPROPRIATE SIZED LAG SCREW WAS INSERTED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13615152 ↗
• InjuryAug 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE COMPRESSION SCREW COULD NOT GO THROUGH THE NAIL. IT IS UNKNOWN WHETHER THE META-TAN DRILL GUIDE, THE META-TAN DROP, THE META-TAN COMP SCREW DRILL OR THE META-TAN COMP SCREW STARTER DRILL CAUSED THIS PROBLEM. A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED TO COMPLETE THE PROCEDURE WITHOUT ANY DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271541 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A META-TAN DRILL GUIDE, A PERCUTANEOUS GUIDE BOLT, AND A CANNULATED IMPACTOR - LONG BROKE. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. IT IS UNKNOWN IF SURGERY WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885782 ↗
• MalfunctionNov 4, 2020Break; Break

  IT WAS REPORTED THAT THE META-TAN DRILL GUIDE HAS BECOME BROKEN. THIS WAS DISCOVERED AFTER AN OPERATION. THERE WAS NO CASE OR PATIENT AFFECTED.

  Patient problems: No Patient Involvement

  MAUDE report 10786299 ↗

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