IMHS 71152151Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010519092), received between Oct 4, 2018 and Mar 2, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionMar 2, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INNER SLEEVE OF THE LAG SCREW REMOVAL WRENCH BROKE WHEN REMOVING THE LAG SCREW. DEVICE'S RETAINING ROD HAD TO BE CUT TO REMOVE THE LAG SCREW. A DELAY OF 3 HOURS WAS REPORTED. NO INJURY REPORTED. NO BACK UP DEVICE AVAILABLE WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384627 ↗
• MalfunctionFeb 28, 2019Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, SCREW REMOVAL WRENCH BROKE DURING REMOVAL OF THE LAG SCREW. NO DELAY WAS REPORTED AND PROCEDURE WAS COMPLETED BY PUSHING THE CENTERING SLEEVE IN AND REVEALING THE END OF THE LAG SCREW. THE RETAINING ROD WAS CUT TO ALLOW THE REMOVAL WRENCH TO ATTACH TO THE LAG SCREW AS ONLY A TINY BIT OF THE END OF THE LAG SCREW WAS REVEALED. NO DELAY AND NO HARM TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380842 ↗
• MalfunctionOct 4, 2018Defective Device

  IT WAS REPORTED THAT THE DEVICE DID NOT REMOVE THE LAG SCREW.

  Patient problems: No Information

  MAUDE report 7935410 ↗

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