TRIGEN 71675514Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556344392), received between Aug 31, 2021 and Aug 31, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K040212, K241804); 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.

• InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY, PERFORMED ON (B)(6) 2020, THE POST OPERATION X-RAYS ON (B)(6) 2021 SHOWED THE INTERTAN 10S 10MM X 38CM 130D LEFT AND THE INTERTAN LAG/COMPRESSION SCREW KIT 100MM / 95MM ARE BACKING OUT, DESPITE BEING LOCKED IN THE CASE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN, AS WELL AS, HOW THE PROBLEM IS GOING TO BE TREATED.

  Patient problems: Failure of Implant

  MAUDE report 12399729 ↗
• InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY, PERFORMED ON (B)(6) 2020, THE POST OPERATION X-RAYS ON (B)(6) 2021 SHOWED THE INTERTAN 10S 10MM X 38CM 130D LEFT AND THE INTERTAN LAG/COMPRESSION SCREW KIT 100MM / 95MM ARE BACKING OUT, DESPITE BEING LOCKED IN THE CASE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN, AS WELL AS, HOW THE PROBLEM IS GOING TO BE TREATED.

  Patient problems: Failure of Implant

  MAUDE report 12395851 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K241804. 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