TRIGEN 71675511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556344248), received between Oct 27, 2017 and Dec 13, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Align” (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 A LEFT IMN FIXATION SURGERY PERFORMED ON (B)(6) 2018 DUE TO A DISPLACED INTERTROCHANTERIC FRACTURE OF THE FEMUR, THE PATIENT REQUIRED CONVERSION TO A LEFT HIP THR DUE TO FRACTURE NONUNION ON (B)(6) 2018. 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20924858 ↗
• InjuryNov 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2016 TO TREAT A FEMORAL SHAFT AND INTERTROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED PAINFUL NONUNION OF THE FEMORAL SHAFT FRACTURE AND BREAKAGE OF THE TWO (2) DISTAL INTERLOCKING SCREWS 46.7 WEEKS POSTOPERATIVELY (AS CONFIRMED PER X-RAY ASSESSMENT). A REVISION SURGERY WAS PERFORMED ON 23-AUG-2017 TO TREAT THIS ADVERSE EVENT. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15741080 ↗
• InjuryOct 27, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHEN INSERTING THE ANTI ROTATION BAR INTO THE FEMORAL HEAD THE OPERATORS NOTICED IT CONVERGED WITH THE 3.2MM X 343MM GUIDE PIN. THEY TRIED A NEW GUIDE PIN AS THEY DISCOVERED IT WAS BENT, ONLY TO HAVE THE SAME RESULT. WHEN THEY REMOVED THE NEW ONE IT WAS BENT TOO. THEY REMOVED THE WHOLE NAIL AND NOTICED THE SET SCREW HAD DROPPED POSSIBLY BENDING THE GUIDE PIN ON ENTRY. THEY WERE NOT SURE WHY THE SET SCREW HAD DROPPED BUT THERE WAS SOME FEELING THE 4.7MM HEX HAD BEEN INCORRECTLY USED TO TRY TO ATTACH THE NAIL TO THE JIG. SURGICAL DELAY OCCURED DUE TO THIS BUT TO NO ADVERSE OUTCOME TO THE PATIENT.

  Patient problems: Injury

  MAUDE report 6984408 ↗

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,