TRIGEN 71677100Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010563323), received between Nov 13, 2019 and Jun 10, 2026 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN INTERNAL FIXATION HIP SURGERY DURING WHICH S+N NAILS, SCREWS, AND ROD WERE IMPLANTED. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PAIN IN THE LEFT LEG DUE TO A FALL. X-RAYS CONFIRMED THAT THE NAILS, SCREWS, AND ROD WERE FRACTURED. THE PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY TO RESOLVE THE ISSUE. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fall; Implant Pain; Loss of fracture reduction

  MAUDE report 25460226 ↗
• InjuryOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PERFORMED ON (B)(6) 2025 DUE TO A FEMORAL FRACTURE, THE IMPLANTED LAG/COMP SCREW KIT 100/95 FRACTURED, REQUIRING A REVISION SURGERY PERFORMED ON (B)(6) 2025 FOR ITS EXPLANTATION AND TO IMPLANT A TRIGEN META RETROGRADE NAIL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23302026 ↗
• InjuryMar 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT HAD THE COMPRESSION SCREW BROKE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LAG/COMP SCREW KIT 100/95, THE INTERTAN 11.5MM X 18CM 125D AND THE TRIGEN LOW PROFILE SCREW 5.0MM X 40MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21548687 ↗
• MalfunctionFeb 20, 2025Nonstandard Device; Delivered as Unsterile Product; Unsealed Device Packaging; Nonstandard Device; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A LAG/COMP SCREW KIT 100/95 WAS TAKEN FROM SHELF AND OUTER PACKAGING OPENED. UPON OPENING FOUND INNER PACKAGING TO BE DAMAGED AND DEEMED TO BE UNSTERILE. UNABLE TO BE USED. OUTER PACKAGING AND PLASTIC WAS INTACT. INNER PACKAGING ONLY DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420905 ↗
• 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 PERFORMED ON (B)(6) 2017 DUE TO A DISPLACED MIDCERVICAL FRACTURE OF THE FEMUR, THE PATIENT REQUIRED A SUBTROCHANTERIC LAG SCREW EXCHANGE DUE TO REDUCED RANGE OF MOTION AND PERSISTENT PAIN. THIS PROCEDURE WAS PERFORMED 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: Implant Pain; Loss of Range of Motion

  MAUDE report 20916979 ↗
• InjuryDec 2, 2024Adverse 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) 2024, THE PATIENT WAS BROUGHT TO REVISE AN INTERTAN THAT WAS DEEMED A MALUNION PER THE SURGEON. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE SURGEON WAS EVENTUALLY ABLE TO REMOVE THE LAG AND NAIL THAT WERE INITIALLY IMPLANTED AND THEN THEN RE-IMPLANTED AN INTERTAN NAIL SUCCESSFULLY. THE PATIENT LEFT SURGERY IN GOOD HEALTH. NO INJURY TO PATIENT.

  Patient problems: Malunion of Bone

  MAUDE report 20825336 ↗
• InjuryDec 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY PERFORMED ON (B)(6) 2024, THE COMPRESSION SCREW PORTION OF THE LAG/COMP SCREW KIT 100/95 WAS FOUND TO BE BROKEN OFF. THE FRACTURED SCREW WAS NOT NOTICED BEFORE PREFORMING THE REVISION. IT SUBSEQUENTLY BROKE OFF AT THE HEX MAKING IT IMPOSSIBLE TO UTILIZE THE HEX DRIVER FOR REMOVAL. AFTER SERVAL HOURS AND ATTEMPTS...FINALLY CAME OUT AFTER MAKING AN OSTEOTOMY, A METAL CUTTING BUR TO CUT THE NAIL AND A CONICAL REAMER OVER THE COMPRESSION SCREW. THE SURGEON WAS EVENTUALLY ABLE TO REMOVE THE LAG AND NAIL THAT WERE INITIALLY IMPLANTED. THE PATIENT LEFT SURGERY IN GOOD HEALTH. NO INJURY TO PATIENT.

  Patient problems: Laceration(s)

  MAUDE report 20825275 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TROCHANTERIC ANTEGRADE NAIL SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT SUFFERED FROM OSTEOPOROSIS, AND THE LAG/COMP SCREW KIT 100/95 PUSHED INTO THE ACETABULUM. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024 IN WHICH THE LAG/COMP SCREW KIT 100/95 WAS EXPLANTED, AND A SHORTER 90/85 VERSION OF THE SAME STYLE LAG SCREW WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20759791 ↗
• InjurySep 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE REMOVAL OF AN INTERTAN NAIL IMPLANTED ON (B)(6) 2022, THE LAG/COMP SCREW KIT 100/95 FRACTURED OFF. DUE TO THIS INCIDENT, THE REMOVAL OF THE NAIL AND THE SCREW WAS CANCELLED. SURGEON WAS GOING TO TRY TO DRILL A 3.5MM WHOLE IN THE SCREW-CORPUS TO TRY TO REMOVE IT WITH A SCREW-EXTRACTION DEVICE. A REVISION SURGERY TO REMOVE THE HARDWARE WAS PERFORMED ON (B)(6) 2024. UNFORTUNATELY, THE HARDWARE COULD NOT BE REMOVED AND THE SURGERY WAS CANCELLED ONCE MORE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20156948 ↗
• MalfunctionAug 13, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, UPON OPENING IT WAS DISCOVERED THAT THE INNER STERILE PACKAGING OF THE LAG/COMP SCREW KIT 100/95 WAS SEVERELY DAMAGED. THE OUTER PACKAGING IS FREE OF DAMAGE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972845 ↗
• InjuryDec 23, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TRAUMA PROCEDURE ON (B)(6) 2021, A TRIGEN INTERTAN LAG SCREW HAS MIGRATED LATERALLY SINCE (B)(6) 2021 - (B)(6) 2021. UPCOMING REVISION SURGERY EXPECTED ON (B)(6) 2021. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13080411 ↗
• 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 12953291 ↗
• InjurySep 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021, IT WAS FOUND THAT THE COMPRESSION SCREW WAS BROKEN. AFTER CUTTING THE FEMORAL HEAD, THE LAG AND COMPRESSION SCREWS WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 12475683 ↗
• InjurySep 1, 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, POST-OP X-RAYS SHOWED THAT THE SCREWS ARE BACKING OUT OF AN INTERTAN 11.5MM X 20CM 125D NAIL, DESPITE BEING LOCKED IN THE CASE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS SOLVED. CURRENT HEALTH STATUS OF PATIENT IS ALSO UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12410765 ↗
• InjuryAug 31, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERTAN NAIL SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE LAG/COMP SCREWS WERE BACKING OUT DESPITE BEING LOCKED IN THE CASE. THIS WAS NOTICED ON A POST-OP X-RAY. A REVISION SURGERY IS PLANNED. AN ADDITIONAL SURGERY IS GOING TO BE PERFORMED. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 12399951 ↗
• InjuryAug 31, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER A TRAUMA PROCEDURE, (1) INTERTAN 1.5 11.5MMX42CM 130D RT AND (1) LAG/COMP SCREW KIT 100/95 HAVE SHOWED ON POST OP X RAYS THAT THE SCREWS ARE BACKING OUT, DESPITE BEING LOCKED IN CASE. IT IS UNKNOWN HOW IS THIS PLANNED TO BE TREATED/SOLVED, PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12395533 ↗
• InjuryAug 31, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER A PATIENT HAD AN INTERTAN 10S 10MM X 38CM 125D RIGHT AND A LAG/COMP SCREW IMPLANTED ON (B)(6) 2020, A POSTOPERATIVE X-RAY SHOWS THE SCREWS BACKING OUT, DESPITE BEING LOCKED IN THE CASE. IT REMAINS UNKNOWN HOW THIS PROBLEM WAS SOLVED. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12395258 ↗
• InjuryMay 6, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT AFTER PLACING THE NAIL IN A CEPHALOMEDULAR FRACTURE REDUCTION SURGERY, THE CEPHALIC FIXATION WAS CARRIED OUT THROUGH THE KIT OFFERED BY THE SYSTEM AND IT WAS DONE STEP BY STEP ACCORDING TO THE SURGICAL TECHNIQUE, BUT WHEN THE LAG/COMP SCREW KIT 100/95 WAS PLACED, IT WAS EVIDENT THAT THE SLIDING SCREW AND THE PIN MOVED IN A DIFFERENT WAY FROM ITS INITIAL POSITION. FOR THIS REASON THE SCREWS WERE REMOVED TO REPOSITION THE PIN INTO THE REQUIRED POSITION. ONCE THIS WAS ACHIEVED, THE SLIDING SCREW WAS PLACED WITHOUT NOVELTIES AND THE LAG/COMP SCREW KIT 100/95 WAS PLACED BUT DID NOT SLIDE THROUGH THE SLIDING SCREW. THEREFORE, AN ALTERNATIVE S+N DEVICE (LAG/COMP SCREW KIT 95/90) WAS USED INSTEAD TO COMPLETED THE PROCEDURE THAT WAS CARRIED OUT WITHOUT ANY SIGNIFICANT DELAYS. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781910 ↗
• InjuryApr 1, 2020Break; Break

  IT WAS REPORTED PATIENT UNDERWENT THROUGH A PER-TROCHANTERIC FRACTURE. THE SAME WAS FIXED WITH A TRIGEN INTERTAN INTERLOCKING SCREW LAG SCREW 100MM/COMPRESSION SCREW 95MM. REVISION SURGERY WAS PERFORMED AND IT WAS NOTICED THAT THE DEVICE MENTIONED WAS BROKEN. THE SURGEON ASSOCIATES THIS FRACTURE WITH CONTINUOUS LOADING CYCLES AND SUBSEQUENT FATIGUE OF THE DEVICE.

  Patient problems: Injury

  MAUDE report 9914321 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE AT THE POINT OF THE LAG/COMPRESSION SCREW COMBO. IT BROKE INSIDE THE PATIENT, AND ALL PIECES WERE RECOVERED. BACK-UP USED TO COMPLETE THE PROCEDURE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318096 ↗

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-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• 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-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,