TRIGEN 71675532Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556345290), received between Jun 4, 2020 and Dec 17, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED THE FRACTURE OF ONE (1) INTERTAN 10S 10MM X 34CM 130D RIGHT AT THE LEVEL OF THE FEMORAL NECK SCREWS. THE SUSPECTED CAUSE IS A PSEUDARTHROSIS AND INSTABILITY. THE NAIL IS STILL IN SITU; NO FURTHER SURGERY HAS TAKEN PLACE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23827210 ↗
• MalfunctionSep 2, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT A 38CM NAIL WAS INSIDE THE INTERTAN 10S 10MM X 34CM 130D RIGHT BOX. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SN BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349687 ↗
• InjuryOct 19, 2020Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY A INTERTAN 10S 10MM X 34CM 130D RIGHT NAIL WAS OPENED AND INSIDE THE BOX WAS A 10 X 34 NAIL AND STICKER CONFIRMED AS WELL. AFTER PUTTING THE NAIL DOWN AND FEELING SOME RESISTANCE THE DOCTOR CHECKED X-RAYS AND SAW THE NAIL WAS WAY TOO LONG. THE DOCTOR TOOK THE NAIL OUT AND SAW THAT IT WAS A 10MM X 38CM 125D RIGHT NAIL AS MARKED ON THE NAIL. PROCEDURE WAS DELAYED FOR LESS THAN 30 MIN AND AN S+N BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10697515 ↗
• MalfunctionAug 18, 2020Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE THE PROCEDURE DURING THE INSPECTION, A 130-DEGREE NAIL WAS NEEDED, BUT WHEN THE PACKAGE WAS OPENED A 125-DEGREE NAIL WAS COMING, SO THE AVAILABLE BACKUP WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10421740 ↗
• MalfunctionJun 4, 2020Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping; Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT, DURING SURGERY, THE PACKAGING OF THE IMPLANT TO BE USED (INTERTAN 10S 10MM X 38CM 125D RIGHT) CONTAINED A DIFFERENT IMPLANT (INTERTAN 10S 10MM X 34CM 130D RIGHT). THE PROCEDURE WAS FINISHED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES BY USING A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118477 ↗

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-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,