TRIGEN 71674023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010560520), received between Oct 7, 2019 and Mar 25, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT INSTRUMENTS WERE NOTICED TO NOT FIT TOGETHER EASILY DURING SURGERY AND GUIDE PIN WAS INSERTED ON INCORRECT ANGLE. LAG SCREW DRILL WOULD ALSO NOT PASS THROUGH NAIL PROPERLY AND SURGEON HAD TO FREE HAND DRILL WITHOUT THE USE OF GUIDE. IT IS SUSPECTED THAT THE LAG SCREW DRILL SLEEVE WAS BENT AT SOME POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568079 ↗
• MalfunctionOct 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING SURGERY THE SLEEVE DOES NOT CLOSE ADEQUATELY. NEITHER THE GUIDE PIN OR THE ANTI-ROTATION BAR ENTER ADEQUATELY AND NEED TO BE FORCED TO ENTER. MORE THAN 2 HOURS DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE BUT NOT STERILE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163288 ↗

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