TRIGEN 71674083Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010560803), received between Oct 2, 2020 and Jun 12, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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.

• MalfunctionJun 12, 2026Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERTROCHANTERIC FRACTURE SURGERY, USING TWO (2) 4.0MM DRILL SLEEVE THAT WERE BENT, THE DRILL AND SCREW WERE FREQUENTLY OFF TRAJECTORY AND MISSING THE SCREW HOLE IN THE NAIL THROUGH THE GUIDE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO A PERFECT CIRCLE TECHNIQUE. NO ADDITIONAL INCISIONS OR REMOVAL OF BONE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485269 ↗
• InjuryOct 2, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY WHILE THE INSTRUMENT WAS OUTSIDE THE PATIENT, THE INTERTAN DISTAL SCREW TARGETING SETUP FAILED CAUSING SURGEON TO DRILL INTO NAIL., SURGEON FREE HANDEDLY RESET THE DRILL AND THE PROCEDURE WAS COMPLETED WITH THE SAME NAIL, AND IT DOES NOT AFFECT THE SURGICAL TECHNIQUE. DELAY REPORTED OF LESS OR EQUAL THAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 10618445 ↗

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