TRIGEN 71675386Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556343692), received between Mar 20, 2018 and Nov 11, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER AN INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2024, PATIENT EXPERIENCED BREAKAGE OF THE NAIL. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON AN UNKNOWN DATE, IN WHICH, THE DEVICE WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 20649497 ↗
• InjuryOct 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER RIGHT FEMUR OSTEOSYNTHESIS SURGERY HAD BEEN PERFORMED ON (B)(6) 2024 (DUE PER TROCHANTERIC AND SUBTROCHANTERIC FRACTURES OF THE RIGHT HIP), DURING REHABILITATION THE PATIENT EXPERIENCED AN EPISODE OF PAIN THAT OCCURRED DURING PHYSICAL THERAPY, SINCE THEN SOMETHING HAD BEEN WRONG WITH HIS LEG; HOWEVER, THE PATIENT HAD CONTINUED TO WALK WITH THE ROLLATOR. ON (B)(6) 2024 AN X-RAY CHECK REVEALED A FRACTURE OF THE INTERTAN NAIL AT THE LEVEL THE DISTAL LOCKING SCREW. THIS ADVERSE EVENT WAS REPORTED ON 20-SEP-2024 AND WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INTERTAN 10S 10MM X 20CM 130D WAS EXPLANTED, AND A LONG NAIL WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 20434297 ↗
• InjuryOct 20, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY (UNKNOWN DATE), WHERE A TRIGEN INTERTAN 10S 10MM X 20CM 130DEGREE, A INTERTAN SUBTROCHANTERIC LAG SCREW 11MM X 90MM AND A TRIGEN INTERNAL HEX CAPTURED SCREW 5.0MM X 35MM WERE IMPLANTED, THE TRIGEN INTERTAN 10S 10MM X 20CM 130DEGREE BROKEN INSIDE THE PATIENT JUST ABOVE THE DISTAL SCREW HOLE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED AS WELL AS THE CURRENT HEALTH STATE OF THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 12665443 ↗
• InjuryAug 31, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT, AFTER AN INTERTROCHANTERIC FRACTURE CORRECTION SURGERY WAS PERFORMED ON (B)(6) 2021, THE LAG/COMP SCREW KIT 90/85, THAT WAS ORIGINALLY INSERTED INTO A INTERTAN 10S 10MM X 20CM 130D, FAILED DUE TO A CUT OUT AND THE SCREWS BACKING OUT DESPITE BEING LOCKED IN THE CASE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12400003 ↗
• InjuryAug 12, 2020Break; Break

  IT WAS REPORTED THAT, ABOUT ONE MONTH AFTER A TRAUMA SURGERY IN WHICH AN INTERTAN 10S 10MM X 20CM 130D NAIL HAD BEEN IMPLANTED, IT WAS DISCOVERED THAT THE NAIL HAD BROKEN AT THE DISTAL LOCKING HOLE. NO FALL HAS BEEN ASSOCIATED TO THE INJURY, THE PATIENT UNDERWENT REVISION SURGERY TO CORRECT THE ISSUE. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 10399893 ↗
• InjuryMar 31, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CORRECT AN INTERTAN NAIL BREAKAGE DUE TO STRESS AND FATIGUE.

  Patient problems: Injury

  MAUDE report 9902829 ↗
• InjuryMar 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT WENT FOR A MANDATORY CLINIC CHECK UP AND SURGEON REQUEST A X-RAY FOR THE PATIENT TO SEE HOW THE FRACTURE IS HEALING . NOTED FROM THE X-RAY THAT THE COMPRESSION SCREW IS BACKING OUT WHEREAS THE TOP SCREW IS STILL IN INTACT. ACCORDING TO SURGEON, PATIENT IS WALKING IN AWKWARD POSTURE . NO PAIN SO FAR. COMPRESSION SCREW BACK OUT OF 1 CM.

  Patient problems: No Information

  MAUDE report 7355630 ↗

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-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