TRIGEN 71675211Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010565167), received between Sep 20, 2017 and Oct 20, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2021Break; Break

  IT WAS REPORTED THAT, AFTER INTERNAL FIXATION SURGERY WAS PERFORMED IN AN UNSPECIFIED DATE, A TRIGEN INTERTAN 11.5MM X 20CM 130 DEGREE NAIL BROKE INSIDE THE PATIENT AT THE LAG SCREW HOLE, ON (B)(6) 2021. IT IS UNKNOWN HOW THIS ISSUE WAS RESOLVED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12665533 ↗
• InjuryJul 9, 2021Break; Break

  IT WAS REPORTED THAT, AFTER INTRAMEDULLARY NAIL SURGERY ON (B)(6) 2020, THE INTERTAN 11.5MM X 20CM 130D BROKE IN THE PROXIMAL PORTION ABOVE THE SINGLE LAG SCREW. A REVISION SURGERY WAS MADE ON (B)(6) 2021 TO REMOVE AND REPLACE IT WITH A COMPETITOR DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 12144816 ↗
• InjurySep 17, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO THE PATIENT DUE TO IT WAS FOUND BY FLUOROSCOPY THAT THE NAIL WAS BROKEN.

  Patient problems: Injury

  MAUDE report 7883440 ↗
• MalfunctionSep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FLUOROSCOPY MEDICAL INTERVENTION WAS PERFORMED TO THE PATIENT DUE TO PAIN WHICH INCREASED AS THE DAYS PASSED.

  Patient problems: Pain

  MAUDE report 7881274 ↗
• InjurySep 20, 2017Fracture; Fracture

  APPROXIMATELY 6 MONTHS AFTER BEING IMPLANTED, THE NAIL BROKE IN PROXIMAL PART. REVISION FOR TOTAL HIP REPLACEMENT WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 6878273 ↗

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-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• 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-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