TRIGEN 71675291Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010561008), received between Sep 30, 2020 and Feb 10, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K040212); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED IN 2023, THE PATIENT EXPERIENCED GRADUALLY DEVELOPMENT OF PAIN. THE COMPRESSION SCREWS OF THE INTERTAN 11.5MM X 38CM 130D LT WERE PROTRUDING, CAUSING DISCOMFORT AND PAIN. IT WAS FOUND THAT THE TOP SECTION OF ONE (1) INTERTAN 11.5MM X 38CM 130D LT BROKE, LEAVING DISTAL NAIL SECTION, AND THERE WAS NON-UNION OF THE FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE INTERTAN 11.5MM X 38CM 130D LT WAS EXPLANTED. FEMORAL SHAFT WINDOW WAS MADE TO MALLET NAIL OUT OF PATIENT. INDENTATIONS WERE MADE ON ANTERIOR SIDE TO BE ABLE TO MALLET NAIL OUT. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

  Patient problems: Discomfort; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 24310290 ↗
• InjurySep 30, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY OF A BROKEN NAIL WAS PERFORMED. THIS EVENT OCCURRED SEVEN MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10604427 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212. One submission often covers many models, so check the product and lot details in each record.

• Z-1133-2022 · Apr 22, 2022 · Open, Classified
  INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
• Z-0772-2021 · Nov 2, 2020 · Terminated
  Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long
• Z-0097-2018 · Oct 24, 2017 · Open, Classified
  smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
• Z-2258-2014 · Jul 2, 2014 · Terminated
  TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71
• Z-1637-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree
• Z-1636-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204,