TRIGEN 71675205Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010565389), received between Feb 6, 2018 and Sep 29, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PERFORMED ON (B)(6) 2025 DUE TO A FEMORAL FRACTURE, THE IMPLANTED INTERTAN 11.5MM X 20CM 125D AND LAG/COMP SCREW KIT 100/95 FRACTURED, REQUIRING A REVISION SURGERY PERFORMED ON (B)(6) 2025 FOR ITS EXPLANTATION AND TO IMPLANT A TRIGEN META RETROGRADE NAIL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23173772 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A FALL THAT REFRACTURED THE FEMORAL SHAFT. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) INTERTAN 11.5MM X 20CM 125D, ONE (1) LAG/COMP SCREW KIT 105/100 AND ONE (1) TRIGEN LOW PROFILE SCREW 5.0MM X 37.5MM WERE EXCHANGED TO ONE (1) INTERTAN 1.5 13X44 125D LT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22836812 ↗
• InjuryAug 31, 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, POST-OP X-RAYS SHOWED THAT THE SCREWS ARE BACKING OUT OF AN INTERTAN 11.5MM X 20CM 125D NAIL, 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12396605 ↗
• InjuryJul 1, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER AN INTERNAL FIXATION SURGERY, PERFORMED ON (B)(6) 2021, SCREWS OF META-TAN LAG/COMP KIT 100/95 ((B)(4)) WERE USED THROUGH AN INTERTAN 11.5MM X 20CM 125D ((B)(4)), LEADING TO EARLY IMPLANT FAILURE. WITH SOME FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THERE WAS NO SALES REP PRESENT AT THE ORIGINAL OPERATION, AND THE ERROR WAS MADE BY A JUNIOR CLINICIAN AT POINT OF SURGERY. THE SURGEON AND HOSPITAL DO NOT BLAME THE IMPLANTS AT ALL, AND THE METATAN SCREWS HAVE NOW BEEN MORE CLEARLY LABELLED FOR FUTURE REFERENCE. THIS ISSUE WAS RESOLVED WITH A REVISION PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12105179 ↗
• InjuryFeb 6, 2018Break; Break

  IT WAS REPORTED THE NAIL IMPLANTED BROKE TWO MONTHS POST OPERATION. NO FALL OR ACUTE TRAUMA REPORTED. REVISION SURGERY SCHEDULED ALREADY.

  Patient problems: Injury

  MAUDE report 7243977 ↗

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,