TRIGEN 71677105Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010563330), received between Sep 3, 2019 and May 5, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 reports).

10 other recalls cover devices cleared under the same FDA submission (K040212, K210980); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERTAN SURGERY HAD BEEN PERFORMED IN (B)(6) 2024, THE COMP SCREW KIT 105/100 WAS DISCOVERED BROKEN. THE PATIENT DID NOT HAD SYMPTOMS OF PAIN AS WELL AS NO TRAUMATIC EVENT. THE IMPLANT REMAIN IN THE PATIENT AND DO NOT REQUIRE EXTRACTION AS THE FRACTURE HAS HEALED. NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 21960526 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS CONDUCTED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH A NAIL EXPLANTATION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12979784 ↗
• InjurySep 10, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WITH INTERTAN NAIL HAD BEEN PERFORMED ON (B)(6) 2020, POST-OP X-RAYS SHOWED THAT THE SCREWS ARE BACKING OUT, DESPITE BEING LOCKED IN THE CASE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS SOLVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS ALSO UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12452973 ↗
• InjuryAug 30, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, POST-OP X-RAYS SHOWED THAT THE LAG/COMP SCREW KIT 105/100 OF AN INTERTAN 13MM X 20CM 125D NAIL ARE BACKING OUT, DESPITE BEING LOCKED IN THE CASE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS SOLVED. CURRENT HEALTH STATUS OF PATIENT IS ALSO UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12388742 ↗
• InjuryAug 26, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE NAIL CUT OUT AND THE SCREWS WERE BACKING OUT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12371880 ↗
• InjuryFeb 2, 2021Failure to Align; Failure to Align

  (B)(6) REF (B)(4): IT WAS REPORTED THAT, INTERTAN SURGERY, WHILE DRILLING USING THE 7.0 COMPRESSION SCREW DRILL , THE TIP OF THE DEVICE, ABOUT 3CM, BROKE OFF IN THE PATIENT. THE PIECE WAS RETRIEVED. THE DEPTH OF THE LAG SCREW WAS 105MM WHEN MEASURED BEFORE THE INCIDENT, SO 105MM LAG SCREW WAS INSERTED AFTER THE INCIDENT, BUT IT WAS NOT FULLY INSERTED. THEREFORE, 95MM LAG SCREW WAS INSERTED INSTEAD OF 105MM LAG SCREW. THERE WAS A 10 MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270677 ↗
• InjurySep 3, 2019Break; Break

  IT WAS REPORTED A REVISION SURGERY DUE TO CUT OUT.

  Patient problems: Injury

  MAUDE report 8955219 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• 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,