TRIGEN 71675509Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556344149), received between Aug 15, 2020 and Dec 13, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN IMN FIXATION SURGERY PERFORMED ON (B)(6) 2019 TO TREAT AN UNSPECIFIED FRACTURE OF THE LOWER END OF THE LEFT FEMUR, THE PATIENT SUSTAINED AN UNSPECIFIED PERIPROSTHETIC FRACTURE WHICH REQUIRED AN ORIF PROCEDURE WITH ORTHOPEDIC PLATING ON (B)(6) 2019. 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: Periprosthetic fracture

  MAUDE report 20925452 ↗
• MalfunctionMay 12, 2021Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION OF A TRAUMA SURGERY, IT WAS NOTICED THAT THE SEALED PACKAGING OF THE INNER WRAPPER OF AN INTERTAN 10S 10MM X 34CM 125D LEFT WAS DISASSOCIATED WITH THE PLASTIC, LEAVING A SPOT THAT COMPROMISED STERILITY. SINCE THE WRAPPER WAS NOT ATTACHED ANY LONGER TO THE PLASTIC THERE WAS A HOLE WHERE AIR COULD MOVE IN AND OUT. THIS WAS NOTICED PRIOR TO THE SCRUB TECH TOUCHING OR RECEIVING THE IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810796 ↗
• InjuryAug 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN COMPRESSION SCREW AND NAIL. THE PATIENT COMPLAINED FROM PAIN AND SUBSEQUENT X RAYS SHOWED THE BROKEN IMPLANTS.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 10411796 ↗

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,