TRIGEN 71676557Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556038949), received between Sep 20, 2022 and Dec 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 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 TO TREAT A DISPLACED INTERTROCHANTERIC FRACTURE OF THE FEMUR, THE PATIENT FRACTURE MALUNION AND REQUIRED A CONVERSION TO THR ON (B)(6) 2017. 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: Malunion of Bone

  MAUDE report 20917616 ↗
• InjuryNov 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A LEFT INTERTAN FEMORAL NAIL PROCEDURE, ON (B)(6) 2023, DUE TO A FALL AND SUBSEQUENT SUB TROCHANTERIC FRACTURE. THEY LATER DEVELOPED A VARUS DEFORMITY AND WERE DIAGNOSED WITH A SUB TROCHANTERIC / INTERTROCHANTERIC FEMUR NONUNION WITH FAILED FIXATION, AND THE INTERTAN 1.5 11.5MMX38CM 125D LT NAIL AND THE LAG/COMP SCREW KIT 90/85 WERE FOUND TO BE FRACTURED. THEREFORE, THEY WERE ELECTED FOR A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE NAIL WAS EXPLANTED AND A SYNTHES COMPETITOR DEVICE WAS IMPLANTED. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Anemia; Deformity/ Disfigurement; Failure of Implant; Muscle Weakness/Atrophy; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18156672 ↗
• InjurySep 20, 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) 2019 TO TREAT AN INTERTROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED INCREASED GROIN AND HIP PAIN, AND TROCHANTERIC BURSITIS. THE PATIENT DESCRIBED THE PAIN AS WORSE WITH SITTING AND LYING ON THE LEFT SIDE, BUT IMPROVED WITH STANDING. DURING A FOLLOW UP CONDUCTED IN OR AROUND (B)(6) 2019, THE PATIENT RECEIVED A STEROID INJECTION IN THE LEFT HIP TO RELIEF THESE SYMPTOMS. IN ADDITION, DURING THIS FOLLOW UP, THE FEMORAL FRACTURE WAS CONFIRMED AS REDUCED WITHOUT ANY HARDWARE COMPLICATIONS PER X-RAY EVALUATION. AFTER THIS INTERVENTION, THE PATIENT CONTINUED TO EXPERIENCE PAIN IN THE DEEP POSTERIOR HIP WITH SYMPTOMS OF SCIATICA. 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: Discomfort; Inflammation

  MAUDE report 15459703 ↗

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,