TRIGEN 71677085Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010563293), received between Jul 1, 2018 and Jul 28, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (5 reports).

10 other recalls cover devices cleared under the same FDA submission (K040212, K210980); 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.

• InjuryJul 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN FRACTURE OF THE FEMORAL TROCHANTER. THIS ADVERSE EVENT WAS RESOLVED THROUGH REVISION SURGERY ON (B)(6) 2025 DUE TO THE NAIL BREAKAGE, THE COMPRESSION SCEW BREAKAGE AND PAIN ASSOCIATED WITH PSEUDOARTHROSIS (NONUNION). THE INTERTAN PRODUCTS WARE REMOVED AND HIP REPLACEMENT ARTHROPLASTY WAS PERFORMED.

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

  MAUDE report 22630820 ↗
• InjuryMar 18, 2024Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PROXIMAL PORTION BREAKAGE OF THE NAIL. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE ENTIRE NAIL WAS REMOVED. SURGEON THEN WENT TO REMOVE THE COMPRESSION SCREW, WHICH THEN REALIZED THE TIP WAS BROKEN OFF. HE WAS ABLE TO REMOVE THE COMPRESSION SCREW BY SLIDING AN OSTEOTOME INFERIOR TO THE COMPRESSION SCREW TO CREATE SOME SPACE, AND THEN HE SLID THAT SAME OSTEOTOME IN BETWEEN THE LAG AND COMPRESSION SCREW TO SEPARATE THEM. HE REMOVED THE LAG SCREW AND PULLED THE REMAINING COMPRESSION SCREW OUT WITH A BULLDOG. HE THEN USED A STRYKER NAIL EXTRACTOR TO GET THE REST OF THE NAIL OUT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18927134 ↗
• InjurySep 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2019 TO TREAT AN OBLIQUE SUBTROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED THE FRACTURE OF THE INFERIOR SCREW FROM THE LAG/COMP SCREW KIT FORTY (40) WEEKS POSTOPERATIVELY (IN OR AROUND (B)(6) 2020). PER THE X-RAYS ASSESSED BY THE ATTENDING SURGEON, NO INTERVAL DISPLACEMENT WAS APPRECIATED AND THE NAIL WAS FOUND TO BE INTACT. THE PATIENT'S HEALTH STATUS WAS REPORTED AS "CLINICALLY DOING WELL", WITHOUT ANY OTHER COMPLICATIONS INVOLVED. ADDITIONAL DETAILS REGARDING THE FINAL OUTCOME OF THIS 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.

  Patient problems: Failure of Implant; Insufficient Information; Nonunion/Delayed-union Bone Fracture; Pain; Radiolucent Lines

  MAUDE report 15459731 ↗
• InjurySep 6, 2021Migration; Migration

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED ON (B)(6) 2021, AN INTERTAN 11.5MM X 20CM 125D NAIL FAILED DUE TO A CUT OUT AND THE LAG/COMP SCREWS WERE BACKING OUT DESPITE BEING LOCKED IN THE CASE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2021. PATIENTS CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12430954 ↗
• InjuryNov 5, 2019Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE SURGEON FOUND A SHADOW IN A X-RAY IMAGE. AFTER RECONFIRMING THE IMAGE, HE FOUND SOMETHING REMAINED. THEN THE SAME SURGERY WAS PERFORMED AGAIN USING OTHER IMPLANTS/DEVICES. AFTER PULLING OUT THE NAIL PREVIOUSLY IMPLANTED, A METALLIC PIECE WAS REMOVED FROM THE MEDULLARY SPACE. THEN REMOVING THE METAL MATERIALS AS MUCH AS POSSIBLE, THE SURGERY WAS COMPLETED BY IMPLANTING OTHER NAIL. BACK-UPS AVAILABLE. DELAY GREATER THAN 30 MIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9281433 ↗
• InjuryFeb 11, 2019Break; Break

  IT WAS REPORTED THAT PATIENT WHO HAD INTERTAN OPERATION ON (B)(6) 2017 AT THIS HOSPITAL HAD PAIN AND TOOK X-RAY AT OTHER HOSPITAL, THEN IT WAS NOTED THAT THE NAIL WAS BROKEN. REVISION SURGERY (BHR) WIL BE PERFORMED. NO MORE INFORMATION SHOWN.

  Patient problems: Pain

  MAUDE report 8329847 ↗
• InjuryFeb 11, 2019Break; Break

  IT WAS REPORTED THAT PATIENT WHO HAD INTERTAN OPERATION ON (B)(6) 2017 AT THIS HOSPITAL HAD PAIN AND TOOK X-RAY AT OTHER HOSPITAL, THEN IT WAS NOTED THAT THE NAIL WAS BROKEN. REVISION SURGERY (BHR) WIL BE PERFORMED. NO MORE INFORMATION SHOWN.

  Patient problems: Pain

  MAUDE report 8329455 ↗
• 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 7653966 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• 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