TRIGEN 71677080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010563286), received between Apr 18, 2017 and Feb 28, 2019 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A NAIL WAS EXCHANGE DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8378469 ↗
• DeathOct 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD A HIP BREAKAGE OPERATION, 1 DAY AFTER THE OPERATION PATIENT DIED. ALTHOUGH, PATIENT REPORT STATES IT WAS A NATURAL DEATH.

  Patient problems: Death

  MAUDE report 6926375 ↗
• InjuryMay 9, 2017Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AS THE SCREW BACK-OUT WAS CONFIRMED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6553412 ↗
• MalfunctionApr 18, 2017Fracture; Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF FEMORAL NAIL FOR INTERTROCHANTERIC FRACTURE THE LAG SCREW IS BACKING OUT ABOUT 5 MM BUT COMPRESSION SCREW A LOT. FRACTURE WAS BEING REDUCED WELL INTRA-OP. PATIENT IS DOING FINE WITH DAILY ROUTINE, NO ACTIVE SPORTS ACTIVITIES, NO PAIN. DUE TO NO PAIN THE SURGEON DID NOT TAKE ANY ACTIONS AND PATIENT WILL BE MONITORED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6499653 ↗

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,