TRIGEN 71675221Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010561060), received between Jul 22, 2020 and Jul 22, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, AFTER A NAIL IMPLANTATION HAD BEEN PERFORMED APPROXIMATELY 18 MONTHS AGO TO ADDRESS A REVERSE OBLIQUITY SUB TROCH FRACTURE THAT DEVELOPED INTO A HYPOTROPHIC NON-UNION, THE PATIENT RECENTLY PRESENTED WITH HIP PAIN OF THE OPERATIVE LEG. X-RAYS EXAMINATION REVEALED THAT THE NAIL HAD BROKEN AT THE LAG SCREW APERTURE. A SECOND PROCEDURE WAS PERFORMED TO REMOVE THE BROKEN NAIL AND PLACE A NEW INTERTAN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10307113 ↗

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,