TRIGEN 71631015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010604866), received between Dec 3, 2024 and Dec 3, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING FEMORAL OSTEOSYNTHESIS, THE GUIDE DID NOT HAVE THE RIGHT CALIBER, BECAUSE IT HIT THE WIRE ON THE ROD AND DEVIATED OUTWARDS, NOT FOLLOWING THE SURGICAL PLAN. EVEN THOUGH, SEVERAL ATTEMPTS WERE MADE CORRECTLY, ENDING UP WORSENING THE FOCUS OF THE FRACTURE, AND IT WAS NOT POSSIBLE TO PERFORM THE CEPHALIC BLOCK. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN, WITH A COMPETITOR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20838629 ↗

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