TRIGEN 71751142Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010514776), received between Nov 4, 2020 and Dec 26, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Damaged Thread” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A NAIL EXTRACTION SURGERY, TWO (2) HUMERAL NAIL EXTRACTOR DID NOT FIT. DURING THE SURGERY, THE EXTRACTOR WAS ALSO TESTED ON A NEW NAIL. IT DID NOT FIT EITHER. THE NAILS WERE TESTED WITH THE TWO EXTRACTORS AND ALSO DID NOT FIT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A COMPETITOR DEVICE. THE NAIL WAS REMOVED WITH A STANDARD NAIL REMOVAL INSTRUMENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898297 ↗
• MalfunctionMar 5, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING A NAIL EXTRACTION PROCEDURE, THE HUMERAL NAIL EXTRACTOR HAD NO GRIP SINCE ITS THREADS WERE FLAT. THERE WAS A SIGNIFICANT DELAY, AND THE PROCEDURE WAS COMPLETE BY USING THE FRACTURE FOCUS AND PUSHING THE NAIL TO EXTRACT IT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532047 ↗
• InjuryNov 4, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY OF REMOVING TRIGEN HUMERAL NAIL (PLANNED SURGERY), THE MATING PART ON THE HUMERAL NAIL EXTRACTOR COULD NOT KEEP CAPTURING THE SCREW HEAD. USING A COMPETITOR DEVICE, THE SURGERY WAS COMPLETED. THERE WAS A 30 MINUTES SURGICAL DELAY. THERE WAS NO HARM TO PATIENT.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10786365 ↗

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