TRIGEN 71674086Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010580290), received between Aug 1, 2019 and May 18, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, THE NAIL WAS INSERTED AND THE SUBTROCHANTERIC SCREW PLACEMENT TECHNIQUE WAS PERFORMED, BUT AT THE TIME OF GIVING THE LAST TURNS OF INSERTION, IT WAS NOTICED THAT THE SCREW HANDLE CAME LOOSE. UPON REMOVING THE HANDLE, IT WAS NOTICED THAT ONE (1) SUBTROC LAG SCREW HEXDRVR ROD WAS FRACTURED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211759 ↗
• MalfunctionMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE INTERNAL FIXATION SURGERY, THE SCREW WAS BEING REMOVED AND THE SUBTROC LAG SCREW HEXDRVR ROD BROKE. NOTHING FELL INTO THE INCISION. NO DAMAGE CAUSED, THE PATIENT'S HEALTH CONDITION IS STABLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102056 ↗
• MalfunctionJul 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING REMOVAL OF INTERTAN LAG SCREW, THE TIP OF THE SUBTROC LAG SCREW HEXDRVR ROD WAS BROKEN. THE PIECE WAS REMOVED BY AN UNKNOWN METHOD. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, BUT IT IS UNKNOWN IF THERE WAS A DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711143 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF A SUBTROC LAG SCREW HEXDRVR ROD WAS BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395810 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, IT WAS NOTICED A BROKEN SUBTROC LAG SCREW DRIVER RETAINING ROD. NO PATIENT WAS INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393948 ↗
• InjuryApr 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERTAN EXPLANT SURGERY, IT WAS DIFFICULT TO REMOVE THE LAG SCREW. THE INNER ROD OF THE SUBTROC LAG SCREW HEXDRVR ROD WAS FRACTURED. THE IMPLANTED DEVICES COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED, WITH A SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14097726 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487910 ↗
• MalfunctionApr 2, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT AFTER PROCEDURE, THE TOP PART OF THE SUBTROC LAG SCREW HEXDRIVER ROD WAS NOTICED TO BE BENT AND BROKEN. THE PROCEDURE WAS FINISHED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610659 ↗
• InjuryMar 4, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE THREADS OF INNER CAPTURE FOR SUBTROC LAG SCREW HEXDRIVER ROD SNAPPED DURING EXCISION OF THE NAIL, WHILE USING IT INSIDE THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408844 ↗
• InjuryJun 12, 2020Break; Break

  IT WAS REPORTED THAT THE LAG SCREW CAPTURE ROD BREAK IN SURGERY, IT WAS INSIDE THE PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10149900 ↗
• MalfunctionJun 8, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE SUBTROCHANTERIC DRIVER RETAINING ROD BROKE AT THE THREADING. SMITH& NEPHEW BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10131432 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIP OFF THE RETENTION ROD BROKE WHILE COMPRESSING THE LAG SCREW. NO DELAY NOR INJURY WAS REPORTED. A BACK UP WAS AVAILABLE BUT NOT REQUIRED TO FINISH THE SURGERY. NO FRAGMENTS FELL INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282332 ↗
• MalfunctionAug 1, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, WHILE TIGHTENING A SCREW, THEY HEARD A POP AND THE ROD BROKE. NO DELAY AND NO INJURY. IT IS UNKNOWN HOW THE PROCEDURE WAS CONCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8850804 ↗

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