TRIGEN 71675224Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010561091), received between May 16, 2017 and Jan 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

• InjuryJan 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2015 IN ORDER TO TREAT A COMMINUTED FEMUR FRACTURE, THE PATIENT EXPERIENCED A RUPTURE OF THE INTERTAN 10MM X 36CM 125D RT USED. FUNCTIONAL DISCOMFORT WITH PERSISTENT LIMP AND PROXIMAL RIGHT HIP IMPINGEMENT WERE REPORTED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO REMOVE THE BROKEN CENTROMEDULLARY NAIL. ALSO, AN ISOLATED BONE GRAFTING WAS PERFORMED AS THE FRACTURE WAS CONSOLIDATED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Loss of Range of Motion

  MAUDE report 13282441 ↗
• InjuryMay 16, 2017Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED LESS THAN FOUR MONTHS AFTER SURGERY AFTER THE PATIENT FELT A SNAP AND WAS UNABLE TO WEIGHT-BEAR.

  Patient problems: Injury

  MAUDE report 6570969 ↗

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-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,
• 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