TRIGEN 71675270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010560933), received between Mar 5, 2020 and May 17, 2021 — classified as 2 injuries.

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

• InjuryMay 17, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TRAUMA PROCEDURE ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGE A INTERTAN 10MM X 38CM 130D RT BECAUSE IT WAS BROKEN. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 11832566 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF THE NAIL AT THE LEVEL OF THE HOLE OF THE INTEGRATED SCREWS. THE NAIL WAS REMOVED AND REPLACED BY ONE OF THE SAME LENGTH, BUT OF GREATER DIAMETER. INITIAL SURGERY PERFORMED IN (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 9792432 ↗

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