TRIGEN 71676524Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556039779), received between Jun 12, 2020 and Jun 12, 2020 — classified as 1 injury.

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

6 other recalls cover devices cleared under the same FDA submission (K040212); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN INTERTAN WAS IMPLANTED 7 MONTHS AGO. AFTER THAT, THE PATIENT PRESENTED SYMPTOMS OF PAIN IN THE HIP WHILE WALKING. X-RAYS WERE TAKEN OF THE OPERATIVE HIP AND THESE REVEALED THAT THE WORM DRIVE SCREW WAS BROKEN. THE DISTAL INTER-LOCKING SCREW WAS REMOVED FOLLOWED BY THE DRIVING END OF THE BROKEN WORM DRIVE SCREW. THE FEMORAL NECK WAS THEN RESECTED AND REMOVED THUS EXPOSING THE LAG SCREW AND THE REMAIN PORTION OF THE BROKEN WORM DRIVE SCREW. NEXT, THE NAIL WAS REMOVED. AT THIS POINT, IT WAS DICOVERED THAT THE PROXIMAL END OF THE NAIL WAS ALSO BROKEN AT THE LAG SCREW HOLE. THE REST OF THE NAIL WAS REMOVED AND THE PATIENT RECEIVED A TOTAL HIP. ALL INTER TAN IMPLANTS WERE REMOVED.

  Patient problems: Injury

  MAUDE report 10150916 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212. 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-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,