TRIGEN 71700005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010543233), received between Mar 30, 2021 and May 4, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, A HFN DRILL GUIDE WAS STRIPPED AND WILL NOT ACCEPT THE IMPACTOR DURING NAIL CASE. INSTRUMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773633 ↗
• MalfunctionApr 2, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING USE, OUTSIDE THE PATIENT, THERE WAS TROUBLE WITH THE NAIL DROP AND DRILL GUIDE NOT TARGETING THE DYNAMIC INTERLOCK FOR THE 20CM NAIL. NO OTHER COMPLICATION WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS ANY DELAY TO SURGERY DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610619 ↗
• MalfunctionApr 2, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING SURGERY, THE HFN DRILL GUIDE AND HFN NAIL DROP WERE NOT TARGETING THE DYNAMIC INTERLOCK FOR THE 20CM NAIL. THE PROCEDURE CONTINUED USING THE SAME DEVICES AND NO INJURY TO THE PATIENT WAS REPORTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610611 ↗
• MalfunctionMar 30, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE THE HFN DRILL GUIDE AND HFN DROP WERE NOT TARGETING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND WITH NO SIGNIFICANT DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593390 ↗

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