TRIGEN 71675507Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556344040), received between Jun 10, 2022 and Dec 10, 2024 — classified as 1 injury, 1 malfunction.

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

6 other recalls cover devices cleared under the same FDA submission (K040212, K241804); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A LEFT IMN NAIL REVISION PERFORMED ON (B)(6) 2020 DUE TO A PERIPROSTHETIC LEFT FEMORAL FRACTURE, THE PATIENT EXPERIENCED SYMPTOMATIC HARDWARE WITH PERSISTENT DRAINAGE AND THERE WAS A CONCERN OF IMPLANT INFECTION. THE PATIENT UNDERWENT INTRAMEDULLARY NAIL EXCHANGE WITH PLACEMENT OF ANTIBIOTIC BEADS AND STABILIZATION OF THE PERTROCHANTERIC FEMUR FRACTURE ON (B)(6) 2022. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Medical device site infection

  MAUDE report 20896143 ↗
• MalfunctionJun 10, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, WAS UNABLE TO ADVANCE THE LAG SCREW DRILL BECAUSE THE SET SCREW WAS TOO FAR DOWN THE PROXIMAL END OF THE INTERTAN 10S 10MM X 32CM 125D LEFT. THE DRILL WAS CAUGHT ON THE SET SCREW. SURGERY WAS RESUMED, WITH A GREATER THAN 30 MINUTES DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K241804. 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-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