TRIGEN 71677095Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010563316), received between May 10, 2017 and Jun 30, 2025 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, ONE (1) LAG/COMP SCREW KIT 95/90 HAD TO BE REMOVED. THIS ADVERSE EVENT WAS RESOLVED THROUGH REVISION SURGERY ON (B)(6) 2025, DURING WHICH A SHORTER SCREW WAS INSERTED. THE PATIENT¿S CURRENT STATE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22356672 ↗
• MalfunctionJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERTAN REMOVAL SURGERY (PLANNED SURGERY AFTER HEALING), AS NEW BONE HAD FORMED, IT WAS CAREFULLY REMOVED WITH A CHISEL UNTIL THE HEAD OF THE COMPRESSION SCREW WAS CONFIRMED. WHEN TRYING TO REMOVE IT, A CRACKING SOUND WAS HEARD, THEN THE SCREW WAS TURNED AND ONLY PART OF THE SCREW WAS REMOVED. THE COMPRESSION SCREW WAS FRACTURED AND THE SCREW COULD NOT BE REMOVED. THE INTERTAN NAIL ALSO COULD NOT BE REMOVED EITHER. THE PIECE WAS LEFT IN PATIENT. SURGERY WAS 60 MINUTE DELAY. PATIENT WAS NOT HARMED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055605 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN ORIF SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024 IN WHICH THE LAG SCREW OF ONE (1) LAG/COMP SCREW KIT 95/90 WAS REMOVED AS THE SURGEON DETERMINED THAT IT WAS CAUSING THE PAIN. THE NAIL AND DISTAL SCREW WERE LEFT IN THE PATIENT'S ANATOMY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 20558581 ↗
• InjuryMar 16, 2022Migration; Migration

  *USA LEGAL* IT WAS REPORTED THAT 3 MONTHS AFTER AN ORIF OF A LEFT INTERTROCHANTERIC HIP FRACTURE WAS PERFORMED WITH A TRIGEN INTERTAN NAIL SYSTEM ON (B)(6)2018, THE PATIENT FELT A POP IN HER HIP AND HAD PAIN WITH DIFFICULTY AMBULATION. UPON ARRIVAL TO THE EMERGENCY ROOM, X-RAYS CONFIRMED THAT THE LAG AND COMPRESSION SCREWS WERE NOTED TO BACK OUT SOMEWHAT FROM THE LATERAL CORTEX AND A CT SCAN DEMONSTRATED A COMMINUTED FRACTURE OF THE GREATER TROCHANTER. TO ADDRESS THIS ADVERSE EVENT, THE NAILING SYSTEM WAS REPLACED WITH A THA FROM A COMPETITOR. UPON REMOVAL OF THE NAIL, A FRACTURE ALONG ITS MIDPORTION WAS NOTED. THE PATIENT KEPT EXPERIENCING OTHER ADVERSE EVENTS AFTER THE REVISION SURGERY THAT ARE STILL UNRESOLVED.

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

  MAUDE report 13777610 ↗
• InjuryFeb 8, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER A INTERTAN SURGERY PERFORMED ON (B)(6)-2021. THE LAG/COMP SCREW KIT 95/90 CUT OUT, AND TO SOLVE THIS PROBLEM IT WAS NECESSARY TO PERFORM A THA REVISION SURGERY. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13480243 ↗
• InjuryDec 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED BACKING OUT OF COMPRESSION SCREW. THE OBSERVATION WAS MADE ON (B)(6) 2021. THIS ADVERSE EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13081686 ↗
• MalfunctionNov 16, 2021Fitting Problem; Failure to Align; Fitting Problem; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE LAG/COMP SCREW KIT 95/90 THREADS WERE NOT ALLOWING THE DRIVER TO ENGAGE THE SCREW. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY AS CONSEQUENCE OF THIS ALLEGATION. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823834 ↗
• InjurySep 10, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY ON (B)(6) 2021, A INTERTAN 10S 10MM X 40CM 125D LEFT AND A INTERTAN LAG/COMPRESSION SCREW KIT 95MM / 90MM BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE IT AND INSERT A NEW ONE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12453261 ↗
• InjuryAug 31, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION HAD BEEN PERFORMED ON (B)(6) 2020, ON POST OP X-RAY, SHOWS THE SCREWS BACKING OUT, DESPITE BEING LOCKED IN THE CASE. A REVISION SURGERY WAS PERFORMED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12396338 ↗
• 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 12395427 ↗
• InjuryAug 31, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2020, A POST-OPERATIVE X-RAY REVEALED THAT THE IMPLANTED TRIGEN INTERTAN NAIL SCREWS 95MM / 90MM ARE BACKING OUT DESPITE OF BEING LOCKED IN THE CASE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. NO REVISION SURGERY WAS CONDUCTED. PATIENT'S CURRENT HEALTH STATUS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12394772 ↗
• InjuryAug 19, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE NAIL CUT OUT AND THE SCREWS WERE BACKING OUT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12343574 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2021, THE INTERTAN 10S 10MM X 18CM 125D NAIL FRACTURED ON 16-FEB-2021. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXPLANT THE NAIL SYSTEM. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11687019 ↗
• InjurySep 22, 2020Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A COMPRESSION SCREW COMING OUT. PRIMARY WAS PERFORMED ON (B)(6) 2020 AND REVISION ON (B)(6) 2020. IT IS UNKNOWN THE STATE OF THE PATIENT. NO MORE INFORMATION PROVIDED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10570029 ↗
• InjuryAug 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN COMPRESSION SCREW AND NAIL. THE PATIENT COMPLAINED FROM PAIN AND SUBSEQUENT X RAYS SHOWED THE BROKEN IMPLANTS.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 10411798 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 8609100 ↗
• InjuryMar 6, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER THE OPERATION, IT WAS FOUND ON X-RAY IMAGE THAT THE COMPRESSION SCREW WAS MOVED FROM ITS IMPLANTED POSITION. THE PATIENT IS VERY OLD AND ALMOST BEDRIDDEN PATIENT. SO HE DOESN¿T MOVE ACTIVELY BOTH BEFORE AND AFTER THE SURGICAL. HE MOVES ONLY FOR MOVING BED TO BED, AND FOR TAKING BATH WITH SOMEONE¿S HELP. HE FEELS PAIN WHEN HE MOVES.

  Patient problems: Pain

  MAUDE report 8396595 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  A REVISION WAS REPORTED DUE TO THE FACT THAT THE PATIENT WAS EXPERIENCING PAIN AND IT WAS BELIEVED THAT THE FRACTURE COULD HAVE BEEN GAPPING. AFTER REVISION, THE DOCTOR CONCLUDED THAT IT WAS MOST LIKELY TO HAVE HAPPENED DUE TO PATIENT'S BONE QUALITY.

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

  MAUDE report 6556334 ↗

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,