TRIGEN 71631452Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556399798), received between Aug 3, 2021 and Jun 1, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Use of Device Problem; Failure to Align

  IT WAS REPORTED THAT, DURING A META-TAN SURGERY, THE SURGICAL TEAM REPORTED THAT THE SYSTEM OF ONE (1) META-TAN DROP, ONE (1) META-TAN LAG SCREW DRILL SLEEVE AND ONE (1) META-TAN GUIDE PIN SLEEVE WAS MISALIGN, AS THEY INSERTED A GUIDE WIRE (GUIDE PIN 3.2MM X 343MM) AND WHEN THEY SCREWED THE CANNULATED LAG SCREW OVER THE WIRE, THE WIRE SNAPPED. 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 25354010 ↗
• MalfunctionJan 30, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION (FEMUR FRACTURE IM NAIL) PROCEDURE, THE META-TAN DROP WOULD NOT ENGAGE THE META-TAN LAG SCREW DRILL SLEEVE PROPERLY, AND THEREFORE THE METATAN DRAG SCREW DRILL SLEEVE POTENTIALLY HAD AN UNSPECIFIED ISSUE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CONDITION IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221374 ↗
• MalfunctionJan 4, 2022Flaked; Material Twisted/Bent; Naturally Worn; Flaked; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT A META-TAN DROP 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 13152372 ↗
• 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 12271576 ↗

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