TRIGEN 71675383Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00885556105696), received between Oct 2, 2017 and Sep 14, 2025 — classified as 25 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN ORIF SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BREAKAGE IN THE DISTAL LOCKING PART OF ONE (1) INTERTAN 10S 10MM X 18CM 125D. THE PATIENT DID NOT REPORT ANY FALL OR EXCESSIVE LOAD THAT COULD HAVE CONTRIBUTED TO THE DEVICE FAILURE. THIS ADVERSE EVENT WAS ADDRESSED A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) INTERTAN 10S 10MM X 18CM 125D, ONE (1) INTERTAN SUBTROC LAG 11 X 100 AND ONE (1) TRIGEN LOW PROFILE SCREW 5.0MM X 30MM WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Failure of Implant

  MAUDE report 23048094 ↗
• 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 22628356 ↗
• InjuryFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY, HAD BEEN PERFORMED ON (B)(6) 2025, THE INTERTAN 10S 10MM X 18CM 125D BROKE AT THE LEVEL OF THE DISTAL SCREW HOLE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A INTERTAN 10S 10MM X 18CM 125D WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21313114 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A RIGHT IMN FIXATION PROCEDURE PERFORMED ON (B)(6) 2018 TO TREAT A DISPLACED INTERTROCHANTERIC FRACTURE, THE PATIENT SUSTAINED NONUNION OF THE FRACTURE WHICH REQUIRED THR CONVERSION ON (B)(6) 2019. 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 20887515 ↗
• InjurySep 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN ORIF SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BREAKAGE OF ONE (1) INTERTAN 10S 10MM X 18CM 125D AT THE DISTAL LOCKING SCREW LOCATION. THIS ADVERSE EVENT IS SAID TO BE SOLVED BY A FUTURE REVISION SURGERY, IN WHICH THE INTERTAN NAIL WILL BE REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20300852 ↗
• MalfunctionJul 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE PACKAGE OF AN INTERTAN 10S 10MM X 18CM 125D WAS NOT CLOSED AND STERILE. ONE END OF THE INNER POUCH WAS NOT HEAT SEALED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657048 ↗
• MalfunctionJun 17, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING PROXIMAL FEMUR SURGERY, ONE (1) INTERTAN 10S 10MM X 18CM 125D WAS GOING TO BE USED IN AN OPERATION BUT IT WAS NOT STERILE. THE PACKAGE WAS OPEN IN ONE END. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546855 ↗
• InjuryApr 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER INTRAMEDULLARY NAILING FIXATION SURGERY HAD BEEN PERFORMED ON (B)() 2021, THE PATIENT EXPERIENCED A INTERTAN 10S 10MM X 18CM 125D RUPTURE THAT WAS DISCOVERED IN (B)(6) 2023. IN (B)(6) 2023, A MEDICAL ACCIDENT APPRAISAL WAS CONDUCTED. THE PRODUCT IS STILL INSIDE THE PATIENT'S BODY AND HAS NOT BEEN REMOVED. THE PATIENT IS CURRENTLY BEDRIDDEN AT HOME.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information

  MAUDE report 19122599 ↗
• InjuryMar 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A ORIF SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED TO THE ED ON (B)(6) 2024, REPORTED A FALL ON (B)(6) 2024 WITH CONTINUED RIGHT HIP PAIN. THIS ADVERSE EVENT WAS DIAGNOSED, ON (B)(6) 2024, BY A RADIOGRAPHIC IMAGING THAT SHOWED THE IMPLANT FAILURE AND A FRACTURE. THE X-RAYS REVEALED THE ROD BROKEN PROXIMALLY THROUGH THE SCREW HOLES, AND THE COMPRESSION SCREW WAS BROKEN AT THE MEDIAL BORDER OF THE ROD. THE PATIENT DECLINES A REVISION SURGERY AND IT SEEMS TO BE HEALING IN A VARUS MALUNION WITH A LIMP AND LEG LENGTH DISCREPANCY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 18831529 ↗
• InjuryFeb 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT FELL AND BROKE SAID IMPLANT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A INTERTAN 10S 10MM X 18CM 125D WAS EXCHANGED TO CORRECT THE BROKEN IMPLANT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18728603 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE INTERTAN HAD FAILED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) INTERTAN 10S 10MM X 18CM 125D; TWO (2) LAG/COMP SCREW KIT 95/90 AND ONE (1) TRIGEN LOW PROFILE SCREW 5.0MM X 35MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694491 ↗
• InjuryMay 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AN INTERTAN 10S 10MM X 18CM 125D WAS IMPLANTED ON (B)(6) 2023, BECAUSE OF A LEFT PERTROCHANTERIC FEMUR FRACTURE CAUSED BY A FALL. ON (B)(6) 2023, DURING AN X-RAY CONTROL, IT WAS NOTICED THE NAIL BROKE, WHICH RESULTED IN FRAGMENT DISLOCATION, THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, WHERE S+N THR IMPLANTS WERE PLACED. THIS SECONDARY PROCEDURE IS NOT RELATED TO A FALL. PATIENTS' CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17020432 ↗
• InjuryMar 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TRAUMA SURGERY, TO TREAT A LEFT HIP FRACTURE, WAS PERFORMED ON (B)(6) 2023, PATIENT TWISTED THE LEG IN THE SHOWER ON (B)(6) 2023, HEARD A "POP", BUT DID NOT FALL. THE NEXT DAY, X-RAYS CONFIRMED THAT THE INTERTAN 10S 10MM X 18CM 125D DEVICE HAD BROKEN THROUGH THE DISTAL LOCKING HOLE. A REVISION SURGERY WAS PERFORMED IN ORDER TO CONVERT THE BROKEN INTERTAN TO A LONGER INTERTAN IMPLANT.

  Patient problems: Failure of Implant; Hyperextension

  MAUDE report 16634956 ↗
• InjuryNov 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TRAUMA PROCEDURE ON (B)(6) 2022, AN INTERTAN 10S 10MM X 18CM 125D BROKE POSTOPERATIVELY INSIDE THE PATIENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE NAIL AND REPLACED IT WITH A NEW INTERTAN NAIL. THE SURGEON BELIEVES IT WAS A FATIGUE FRACTURE AS THE PATIENT DID NOT HAVE A FALL OR ANY OTHER TRAUMA. THE PATIENT HAD INCREASING PAIN IN 8 WEEKS LEADING UP TO THE FRACTURE OF THE NAIL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 15715130 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WITH AN INTERTAN SHORT NAIL HAD BEEN PERFORMED ON 2018, THE PATIENT EXPERIENCED AVASCULAR NECROSIS OF FEMORAL HEAD. THE HARDWARE (SHORT NAIL, LAG/COMPRESSION SCREW AND 5.0 LOCKING SCREW) WAS REMOVED ON (B)(6) 2022 PREPARE FOR A TOTAL HIP ARTHROPLASTY. PATIENT IS RECOVERING.

  Patient problems: Necrosis

  MAUDE report 14738567 ↗
• InjuryFeb 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION, THE PATIENT WAS WALKING AND THE TRIGEN INTERTAN 10S 10MM X 18CM 125DEGREE BROKE AND POPPED OFF THE HEAD OF THE FEMUR. THIS PROBLEM WAS TREATED WITH A THR SURGERY, AND AS A CONSEQUENCE THE PATIENT HAS DROP FOOT. ALSO, THE PATIENT PRESENTED AN (B)(6) INFECTION WHICH CAUSED A THIRD SURGERY AND USAGE OF STRONG ANTIBIOTICS WHICH LID TO KIDNEY FAILURE. CURRENT HEALTH STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Discomfort; Failure of Implant; Pain

  MAUDE report 13453333 ↗
• InjuryDec 7, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERTAN SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN POST SURGERY. THE X-RAYS SHOWED BACKING OUT OF THE COMPRESSION SCREW USED WITH AN INTERTAN DEVICE WHICH WAS LOCKED WITH THE SET SCREW. ALSO, THE SURGICAL TEAM ARE STILL DECIDING ON APPROPRIATE TREATMENT FOR THE PATIENT. IT IS UNKNOWN HOW THE ADVERSE EVENT WAS SOLVED AND CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12953177 ↗
• 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) 2020, THE LAG/COMP SCREW KIT 95/90 , THAT WAS ORIGINALLY INSERTED INTO A INTERTAN 10S 10MM X 18CM 125D, WAS NOTICED FROM POST OP X-RAY EVALUATION TO BE BACKING OUT DESPITE BEING LOCKED IN THE CASE. IT IS UNKNOWN IF A REVISION SURGERY HAS ALREADY BEEN PERFORMED OR SCHEDULED TO TREAT THIS ADVERSE EVENT. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12395715 ↗
• InjuryMay 31, 2021Break; Break

  IT WAS REPORTED THAT, AFTER THE TRAUMA SURGERY PERFORMED ON (B)(6) 2021, THE INTERTAN 10S 10MM X 18CM 125D BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE LAG/COMP SCREW KIT 95/90 AND THE TRIGEN LOW PROFILE SCREW 5.0MM X 35MM WERE ALSO EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11909911 ↗
• MalfunctionMay 10, 2021Manufacturing, Packaging or Shipping Problem; Scratched Material; Manufacturing, Packaging or Shipping Problem; Scratched Material

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, THE SURGEON WANTED TO USE A INTERTAN 10S 10MM X 18CM 125D FOR A HIP FRACTURE CASE. WHEN THE OR CIRCULATOR OPENED THE STERILE BOXED NAIL, THE WHITE STICKER ON THE CLEAR NAIL WRAPPER WAS FOUND PARTIALLY PEELED AND THERE WERE SCUFF MARKS ON THE NAIL. INSTRUMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803350 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, HE PATIENT UNDERWENT A PRIMARY SURGERY ON (B)(6) 2021, DUE TO BREAKAGE OF THE INTERTAN NAIL ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11686972 ↗
• InjuryJan 2, 2021Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE NAIL BREAKAGE. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103618 ↗
• InjuryDec 17, 2020Break; Break

  IT WAS REPORTED THAT THE NAIL THAT THE PATIENT HAD IMPLANTED WAS BROKEN, BUT AS THE PATIENT IS OLD, THE DOCTORS DECIDED TO NOT INTERVENE. NO MORE INFORMATION AT THE MOMENT

  Patient problems: Failure of Implant

  MAUDE report 11032983 ↗
• MalfunctionJun 29, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY UPON TRYING TO ATTACH NAIL TO GUIDE, THE SCRUB TECH COULD NOT GET THE GUIDE BOLT TO TURN MORE THAN AN EIGHTH OF A ROTATION. THE GUIDE WAS FLUSH AGAINST THE TOP OF THE NAIL AND THE NAIL WAS ALIGNED CORRECTLY WITH THE AXIS OF THE GUIDE, NEVERTHELESS AFTER MULTIPLE ATTEMPTS WE TRIED THE SECOND BOLT IN THE SET WITH THE SAME RESULTS. AT THIS POINT THE DR. WANTED A NEW NAIL IN FEAR THAT IF WE TRIED ANYMORE THE NAIL WOULD BECOME CROSS THREADED CAUSING IT TO BIND AND PRESENTING ISSUES WHEN TRYING TO REMOVE GUIDE FURTHER ALONG IN THE SURGERY. A NEW NAIL WAS OPEN AND ATTACHED TO GUIDE WITH NO PROBLEMS AND THE SURGERY WAS COMPLETED AS PER USUAL. NO DELAY NOR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10205125 ↗
• InjuryMay 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT IN (B)(6) 2017, PATIENT HAD A FEMUR FRACTURE AND A ROD AND SCREWS WERE IMPLANTED. PATIENT HAD PAIN UNTIL (B)(6) 2018 WHEN HARDWARE WAS NOTED BROKEN IN SCANS AND THE FEMUR WAS FRACTURED AGAIN DUE TO THE BROKEN HARDWARE. IN (B)(6) 2018 A REVISION SURGERY WAS PERFORMED TO REPAIR THE BROKEN HARDWARE.

  Patient problems: Injury

  MAUDE report 8660943 ↗

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,