TRIGEN 71677090Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010563309), received between Nov 22, 2019 and Nov 16, 2023 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 18156709 ↗
• InjurySep 29, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE LAG SCREW OF A INTERTAN LAG/COMPRESSION SCREW KIT 90MM / 85MM PULLED BACK BEFORE THE COMPRESSION SCREW SEATED. THE SURGEON REMOVED BOTH COMPONENTS OF THE INTERTAN LAG/COMPRESSION SCREW KIT 90MM / 85MM AND RE-DRILLED, BUT IT DID NOT HELP. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502153 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED EARLY COMPRESSION, CAUSING THE LAG/COMP SCREW KIT 90/85 TO BEGIN PULLING FROM THE HEAD OF THE FEMUR. THIS EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE INTERSTRAIN 10S 10MM X 18CM 130D WAS REMOVED. DURING THE REMOVAL, THE TRIGEN LOW PROFILE SCREW 5.0MM X 30MM STRIPPED OUT. SEVERAL TECHNIQUES WERE USED FOR THE REMOVAL, INCLUDING DRIVING THE SCREW TO THE FAR CORTEX, FRACTURING THE FEMUR. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant; Insufficient Information

  MAUDE report 14974285 ↗
• InjuryAug 31, 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) 2020, POST-OP X-RAYS SHOWED THAT THE LAG/COMP SCREW KIT 90/85 OF AN INTERTAN 1.5 11.5MMX40CM 125D RT NAIL ARE BACKING OUT, 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 12399958 ↗
• 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 12394906 ↗
• MalfunctionMay 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TRAUMA HIP SURGERY THE SCRUB TECH INSERTED THE WRONG CAPTURE STICK INTO THE LAG SCREW DRIVER AND NOW IT¿S STUCK ON THE LAG/COMP SCREW KIT 90/85 AND WON'T COME OUT. IT WAS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797484 ↗
• 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 11103619 ↗
• InjuryJun 1, 2020Material Disintegration; Defective Device; Material Disintegration; Defective Device

  IT WAS REPORTED THAT DURING AN INTERTAN CASE, AS THE COMPRESSION SCREW WAS BEING INSERTED UNDER THE LAG SCREW, ONCE COMPRESSION WAS BEING APPLIED, THE SCREW WOULD TIGHTEN AND THEN BOUNCE BACKWARDS. THE SCREW WAS REMOVED FROM THE PATIENT, AND INSPECTED TO SEE SMALL METAL SHAVINGS ON THE THREADS OF THE SCREW. BOTH SCREWS WERE REMOVED AND REPLACED WITH A NEW INTERLOCKING SCREW KIT, WHICH FUNCTIONED AS NORMAL AND COMPRESSED THE FRACTURE. A DELAY WAS PRESENTED LESS OR EQUAL TO 30 MINUTES. IT IS UNKNOWN THE STATE OF THE PATIENT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10105413 ↗
• MalfunctionFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, INSERTED THE COMPRESSION SCREW AND TRACTION WAS REMOVED COMPLETELY AND WHEN COMPRESSION SCREW WAS ALMOST ALL THE WAY DOWN, SURGEON SWITCHED TO THE T HANDLE AND THEN TO BE FINISHED BY HAND. THE SCREW KEPT GETTING TIGHT, BUT DID NOT SHOW ANY SIGN OF COMPRESSING. THEN ALL OF A SUDDEN THE COMPRESSION SCREW WOULD BECOME LOOSE AGAIN. PROCEDURE WAS COMPLETED WITH A NEW SET OF SCREWS THAT WERE INSERTED ONLY BY HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9714950 ↗
• MalfunctionDec 29, 2019Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY, THE COMPRESSION SCREW DID NOT ENTER THE BROCADE GUIDE AND SHOWED REBOUND TO ENTER THE SLIDING SCREW. AT THE END, NO COMPRESSION SCREW IS PLACED, DISTAL LOCKING WAS NOT PERFORMED, NAIL INSERTION ARCH WAS REMOVED, THE SLIDING SCREW BLOCKED AND 0 MM PLUG PLACEMENT WAS PERFORMED, WHICH ALSO DOES NOT FIT PROPERLY INTO THE INTERTAN INTRAMEDULLARY NAIL. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9528704 ↗
• MalfunctionNov 22, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SURGERY, AFTER INSERTING THE LAG/COMP SCREW, IT WAS FOUND THAT THE LAG SCREW WAS LONGER THAN EXPECTED. BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE. NO HARM TO PATIENT. DELAY OF LESS THAN 30 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363696 ↗

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-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