TRIGEN 71700004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010543226), received between Mar 30, 2021 and Oct 8, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, THE SPECIALIST CHECKED THE NAIL LOCKS BEFORE SECURING THEM TO THE NAIL. THEY ARE ALIGNED BY PERFORMING THE FRAME CLICKS ACCORDING TO THE NEEDS OF THE CX. IT WAS NOTICED THAT ONE OF THE BLOCKAGES OF ONE (1) HFN DROP WAS LEFT OUT WHEN THE DRILL BIT WAS PASSED, SO, THE DRILL BIT HIT THE NAIL, WHICH IS WHY THE REPORTED DEVICE WAS DETERMINED TO BE DECALIBRATED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23245704 ↗
• MalfunctionDec 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING MALLEATING, A HFN DROP SNAPPED. SURGERY WAS RESUMED, WITH A SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050311 ↗
• MalfunctionApr 6, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE SCREW ON TOP FELL OUT AND NEEDS TO BE REPLACED. NOTHING FELL INTO PATIENT. NO DELAY IN SURGERY. BACKUP WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624934 ↗
• 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 11610606 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610600 ↗
• 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 11593388 ↗

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