TRIGEN 71675208Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010560872), received between Aug 3, 2017 and Feb 12, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 12, 2026Failure to Align

  IT WAS REPORTED THAT DURING A NAIL PROCEDURE, IT WAS FOUND THAT THE INTERTAN 11.5MM X 18CM 130D COULD NOT ATTACHED TO THE GUIDE BOLT. THE GUIDE BOLT WAS CHANGED TO ANOTHER ONE, BUT THE NAIL COULD NOT ATTACH TO IT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324775 ↗
• InjuryJul 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A INTRAMEDULLARY NAIL SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED A BROKEN NAIL IMPLANTED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A INTERTAN 11.5MM X 18CM 130D WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17303080 ↗
• InjuryFeb 2, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE INTERTAN (B)(6) BROKE AT SIGHT OF PROXIMAL SCREW BODY. THE NAIL WAS REMOVED AND DISTAL END REQUIRED 40 MINUTES TO REMOVE. SURGERY WAS RESUMED, WITH A 40 MINUTES DELAY, WITH A COMPETITOR DEVICE ((B)(6)BLADE PLATE). PATIENT WAS NOT HARMED, OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13430153 ↗
• InjuryOct 22, 2021Break; Break

  IT WAS REPORTED THAT, AFTER INTERNAL FIXATION SURGERY WAS PERFORMED A TRIGEN INTERTAN 11.5MM X 18CM 130 DEGREE NAIL BROKE INSIDE THE PATIENT JUST BENEATH THE INFERIOR COMPRESSION SCREW HOLE. IT IS UNKNOWN HOW THIS ISSUE WAS RESOLVED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12682367 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN CHECKING UNDER X-RAYS, THE DOCTOR UNDERSTOOD THAT HE COULD PLACE AN 11.5MM WIDE NAIL, BUT AFTER STARTING THE SURGERY AND TRYING TO PLACE IT AND RE-DRILL THE BONE SEVERAL TIMES, HE COULD NOT PLACE IT AND DECIDED TO CHANGE TO A 10MM NAIL. NO INFORMATION ABOUT THE PATIENT STATUS WAS INITIALLY PROVIDED.

  Patient problems: Injury

  MAUDE report 10637823 ↗
• InjurySep 28, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A NAIL BREAKAGE. THE PATIENT FELL CAUSING THE DEVICE TO BREAK. IN THIS SURGERY THE LAG AND COMPRESSION SCREWS WERE REMOVED. INITIAL SURGERY WAS PERFORMED 3 YEARS AGO. THE OUTCOME OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10597404 ↗
• InjuryJul 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PT HAS CUT OUT OF NAIL. SCHEDULED FOR REMOVAL OF INTERTAN AND CONVERSION TO TOTAL HIP (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8787715 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED REVISION SURGERY WAS PERFORMED TO REMOVE BROKEN NAIL.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6763722 ↗

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-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• 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-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,