TRIGEN 71674040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010596994), received between Aug 10, 2018 and Mar 5, 2025 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionMar 5, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, IT WAS FOUND THE COLOR CODE ON THE INTERTAN LAG SCREW DRILL HAD BEEN GRADUALLY REMOVED. AFTER REMOVING THE COLOR CODE, THE DEVICE WAS STERILIZED AGAIN. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE AFTER A SIGNIFICANT DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531983 ↗
• InjuryMar 10, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE INTERTAN LAG SCREW DRILL - REAMER SPLIT NOTICED ON X-RAY WHILE IN PATIENT. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720785 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SCREW DRILL INTERFERED WITH SOMETHING INSIDE THE PATIENT, SO THE DEVICE WAS REMOVED FROM THE SURGICAL FIELD AND IT WAS FOUND THE TIP ON THE DEVICE WAS MISSING. ANY PIECE WAS FOUND ON THE X RAY IMAGE. 15 MINUTES DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9528943 ↗
• MalfunctionAug 10, 2018Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED A MALFUNCTION IN WHICH THERE WAS A DELAY LONGER THAN 30 MINUTES. THE DEVICE WAS WORN OUT. THERE WAS NO BACK DURING THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7774047 ↗

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