TRIGEN 71675535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556345443), received between Jul 3, 2020 and Aug 31, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• InjuryAug 31, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER A PATIENT HAD AN INTERTAN 10S 10MM X 38CM 125D RIGHT AND A LAG/COMP SCREW IMPLANTED ON (B)(6) 2020, A POSTOPERATIVE X-RAY SHOWS THE SCREWS BACKING OUT, DESPITE BEING LOCKED IN THE CASE. IT REMAINS UNKNOWN HOW THIS PROBLEM WAS SOLVED. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12394598 ↗
• InjuryJul 3, 2020Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING SURGERY, WHILE DEVICE WAS INSIDE THE PATIENT, IT WAS NOTICED THAT THE INCORRECT ITEM CAME IN THE BOX. THE BOX WAS LABELED WITH PART NUMBER 71675535 WHEN ACTUALLY WHAT WAS IN THE BOX WAS A DEVICE WITH PART NUMBER 71675532. THE CORRECT DEVICE WAS LOCATED AND USED TO COMPLETE THE PROCEDURE. SURGERY WAS NOT DELAYED MORE THAN 30 MIN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10230373 ↗

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