TRIGEN 71675501Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556343746), received between Jul 1, 2018 and Jun 7, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, WHEN DRILLING DISTAL SCREW HOLES, THE DRILL DID NOT TARGET THE HOLE ON THE INTERTAN 10S 10MM X 26CM 125D LEFT. SURGERY WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, BY DRILLING MANUALLY. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627652 ↗
• InjuryMar 9, 2022Break; Break

  IT WAS REPORTED THAT, AFTER SURGERY PERFORMED ABOUT A HALF A YEAR AGO, IT WAS FOUND THAT THE INTERTAN 10S 10MM X 26CM 125D LEFT WAS BROKEN ON (B)(6) 2022. A REVISION SURGERY WITH S+N SLMIA WAS PERFORMED ON (B)(6) 2022. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13711354 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED NAIL BREAKAGE. THE NAIL HAD BEEN BROKEN AT THE LAG SCREW HOLE PART. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY TO EXPLANT THE INTERTAN 10S 10MM X 26CM 125D LEFT ON (B)(6) 2021. IT IS UNKNOWN CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 13212381 ↗
• InjurySep 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PSEUD ARTHROSIS AND A FRACTURE OF THE DEVICE. THE DOCTOR SAYS S+N DEVICES WERE NOT DEFECTIVE. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10570393 ↗
• InjurySep 17, 2020Failure to Align; Defective Device; Failure to Align; Defective Device

  IT WAS REPORTED THAT DURING SURGERY, WHILE CHECKING ALIGNMENT FOR DRILLING THE DISTAL SCREW HOLE USING A TARGETING DEVICE WHICH WAS MADE IN (B)(6) THE DRILL INTERFERED WITH THE NAIL (AROUND STATIC HOLE). THE NAIL WAS USED AND NO RETURN. PROCEDURE WAS COMPLETED BY FREE HANDS. DELAY 60 MINUTES REPORTED. BACKUP DEVICE NOT AVAILABLE. NO INJURY OR IMPACT TO PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551763 ↗
• MalfunctionSep 3, 2020Defective Device; Packaging Problem; Defective Device; Packaging Problem

  IT WAS REPORTED THAT DURING SURGERY, IT WAS FOUND THE INNER PACKAGE OF THE INTERTAN 10S 10MM X 26CM 125D LEFT WAS EXPANDING. AFTER OPENING, TRIED TO PICK UP WITH HAVING "HERE" TAB, BUT IT DIDN'T MOVE. IT WAS ALSO FOUND THE PLASTIC PACKAGE WAS DEFORMED. NO HARM TO PATIENT. NO DELAY. IT IS UNKNOWN IF THERE WAS A S&N BACK UP TO COMPLETE THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 10492283 ↗
• InjuryJul 11, 2020Break; Break

  IT WAS REPORTED THE REVISION SURGERY WAS PERFORMED DUE TO THE INTERTAN NAIL BREAKAGE. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. THE DEVICE WILL BE RETURNED FOR EVALUATION. APART FROM THE INTERTAN 10S 10MM X 26CM 125D LEFT, A LAG/COMP SCREW KIT 90/85, A TRIGEN LOW PROFILE SCREW 5.0MM X 30MM, A TRIGEN LOW PROFILE SCREW 5.0MM X 32.5MM AND A ACC 2.0MM COCR CABLE W/CLAMP WERE ALSO EXPLANTED FROM THE PATIENT.

  Patient problems: Injury

  MAUDE report 10261749 ↗
• InjuryJul 1, 2018Break; Break

  IT WAS REPORTED THAT PATIENT HAD PAIN AND WENT TO THE HOSPITAL. IT WAS FOUND THAT THE IMPLANTED PROXIMAL NAIL AND COMPRESSION SCREW WERE BROKEN.

  Patient problems: Injury

  MAUDE report 7653967 ↗

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,