TRIGEN 71654506Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010585868), received between Sep 6, 2018 and Aug 4, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN ONE (1) GUIDE BOLT WAS BEING LOCKED THE SCREW BROKE LEAVING HALF OF THE THREAD IN THE NAIL. THE SCREW PORTION COULD NOT BE REMOVED AND REMAINED IMPLANTED IN THE PATIENT, THEREFORE, THE PROXIMAL PLUG COULD NOT BE INSERTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE PREVIOUSLY ADDRESSED CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND THE PATIENT´S HEALTH CONDITION IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22709870 ↗
• InjuryNov 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL ORIF, WHILE IMPACTING THE NAIL, A 7/16 GUIDE BOLT BROKE. FURTHERMORE, THE DOCTOR ATTEMPTED TO REMOVE THE BROKEN FRAGMENT WITH SEVERAL INSTRUMENTS AND SUCCEEDED. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A BACKUP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715194 ↗
• MalfunctionOct 21, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE SURGEON STATED THAT IT WAS DIFFICULT TO LINE UP PROPERLY THE GUIDE BOLT AND A STD DRILL GUIDE DURING THE CASE. A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES OCCURRED DUE TO THIS ISSUE, AND A SMITH AND NEPHEW BACKUP DEVICES WERE AVAILABLE TO CONCLUDE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677279 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING TIBIAL SURGERY, A 3.0MM X 1000MM BALL TIP GUIDE ROD AND A META RETRO FEM NAIL 10 X 34 PUNCHED OUT OF THE PACKAGING, OPENING THE SEAL OF THE PACKAGE. ALSO, THE BALL TIP OF THE GUIDE BOLT BROKE FROM THE ROD AND WEDGED INSIDE THE GUIDE BOLT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH BACK-UP DEVICES. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472136 ↗
• MalfunctionJun 8, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE SURGEON STATED THAT IT WAS DIFFICULT TO LINE UP PROPERLY A GUIDE BOLT (CASE: (B)(6)) AND A STD DRILL GUIDE (CASE: (B)(6)) DURING THE CASE. A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES OCCURRED DUE TO THIS ISSUE, AND A SMITH AND NEPHEW BACKUP DEVICES WERE AVAILABLE TO CONCLUDE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962593 ↗
• MalfunctionDec 9, 2020Corroded; Corroded

  IT WAS REPORTED THAT RUST S BUILDING UP INSIDE OF GUIDE BOLT. NO CASE INVOLVED AS THIS WAS FOUND DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978871 ↗
• MalfunctionSep 6, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED A MALFUNCTION IN WHICH THE BOLT THAT FIXES THE NAIL TO EXTERNAL TARGETER BROKE DURING INSERTION OF THE NAIL INTO THE MEDULLARY CANAL, THEN EXTRACTED THE NAIL, REMOVED PART OF THE BROKEN BOLT, REASSEMBLED NAIL ON TARGETER WITH SECOND BOLT SUPPLIED TO URBINO AND THEN REINSERTED THE NAIL. TEN MINUTES DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7850478 ↗

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