TRIGEN 71675202Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010561053), received between May 11, 2017 and Oct 24, 2025 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILE PACKAGING INSIDE THE PACKAGE OF ONE INTERTAN 11.5MM X 18CM 125D WAS NOT SEALED, THEREFORE THE NAIL INSIDE WAS UNSTERILE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384112 ↗
• MalfunctionJul 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, PRIOR TO PATIENT CONTACT, IT WAS FOUND THAT THE BOX OF ONE (1) INTERTAN 11.5MM X 18CM 125D WAS CLOSED; HOWEVER, THE VACUUM-SEALED PLASTIC INSIDE HAD BEEN OPENED AND THEN REPACKAGED. AS A RESULT, THE PRODUCT WAS RENDERED UNSTERILE AND UNSUITABLE FOR USE. 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 22551685 ↗
• InjuryDec 13, 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 SURGERY PERFORMED ON (B)(6) 2020 TO TREAT A PATHOLOGICAL FRACTURE OF THE RIGHT FEMUR, THE PATIENT REQUIRED AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2020 DUE TO A RIGHT THIGH HEMATOMA WITH SUSPECTED INFECTION. HOWEVER, THE LATTER WAS NOT CONFIRMED BASED ON THE RESULTS OF THE INTRAOP. CULTURES TAKEN. 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: Hematoma

  MAUDE report 20925076 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A LEFT HIP CEHPALO-MEDULLARY NAIL REVISION DUE TO SOFT TISSUE INFECTION PERFORMED ON (B)(6) 2020, THE PATIENT REQUIRED A LEFT THA CONVERSION DUE TO INFECTED NONUNION (ENTEROCOCCUS) ON (B)(6) 2020. 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: Bacterial Infection

  MAUDE report 20869279 ↗
• InjuryNov 5, 2024Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE INTERTAN 11.5MM X 18CM 125D BROKE AROUND THE CEPHALOMEDULLARY SCREWS. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INTERTAN 11.5MM X 18CM 125D WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20610059 ↗
• InjuryMar 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A ORIF SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A FALL WITH RIGHT HIP PAIN. THIS ADVERSE EVENT WAS DIAGNOSED BY A RADIOGRAPHIC IMAGING THAT SHOWED THE IMPLANT FAILURE AND A NAIL BROKEN AT PROXIMAL SCREW HOLES. THE X-RAYS REVEALED THE BROKEN ROD AS WELL AS A PERIPROSTHETIC FRACTURE FURTHER DISTAL. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A INTERTAN 11.5MM X 18CM 125D WAS EXCHANGED. IT WAS ABLE TO REMOVE THE PROXIMAL PORTION OF THE ROD THROUGH THE TIP OF THE GREATER TROCHANTER, AND THE DISTAL PORTION OF THE ROD THROUGH THE FRACTURE. THE LAG AND REMAINING COMPRESSION SCREW WERE LEFT IN SITU. THEN THE INTERNAL FIXATION WAS PERFORMED USING A PLATE AND CABLES. PATIENT'S CURRENT HEALTH STATUS IS RECOVERING.

  Patient problems: Arthralgia; Bone Fracture(s); Device Embedded In Tissue or Plaque; Failure of Implant; Fall; Implant Pain

  MAUDE report 18831724 ↗
• InjuryApr 18, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, WHEN BEGINNING TO MAKE THE DRILLING FOR THE PLACEMENT OF THE INTERTAN 11.5MM X 18CM 125D. IT WAS STARTED WITH THE LATERAL CORTICAL DRILL HOWEVER, WHEN PASSING THE NEXT DRILL IT FELT THAT DID NOT ALLOW TO INSERT EASILY, THEREFORE A LOT FORCE WAS USED AS CONSEQUENCE OF THE RESISTANCE. THE DRILL WAS ABLE TO BE INSERTED. AFTER, THE ANTI-ROTATIONAL GUIDE WAS PLACED AND BEGAN TO INSERT THE NEXT DRILL, HOWEVER, HAPPENED THE SAME THING WHERE THERE WAS A LOT OF RESISTANCE. SURGEON CHOSE NOT TO PLACE THE KIT SCREW BUT RATHER A SINGLE SCREW. THE KIT SCREW HAD ALREADY BEEN SCREWED IN AND DECIDED TO REMOVE THE INTERNAL LOCKING SCREW FROM THE NAIL, AFTER SEVERAL ATTEMPTS AND TRYING VERY HARD, IT WAS POSSIBLE TO MAKE THE LAST DRILL HOLE AND PLACE THE KIT SCREW. NONETHELESS, INTERNAL BLOCK OF THE NAIL COULD NOT BE MADE, APPARENTLY IT WAS OUT OF ADJUSTMENT AND COULD NOT BE DONE, OF WHICH THE DOCTOR WAS VERY AWARE AND DECIDED TO LEAVE IT THAT WAY. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16759055 ↗
• MalfunctionJul 5, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT, DURING SURGERY, AN INTERTAN 11.5MM X 18CM 125D WAS IMPLANTED IN THE PATIENT. WHEN THEY TRIED TO LOCK DOWN THE SET SCREW THEY REALIZED THERE WAS NO ONE PRESENT IN THE NAIL. THE PROCEDURE WAS COMPLETED USING AN S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30MINS DELAYED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14912344 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER INTERNAL FIXATION SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE, A TRIGEN INTERTAN 11.5MM X 18CM 125 DEGREE DEVICE WAS EXPLANTED ON (B)(6) 2021. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 12835733 ↗
• InjuryFeb 22, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD THE FIRST SURGERY ON (B)(6) 2020 AND PRESENTED PAIN. AN X-RAY SHOWED A NAIL FRACTURED. REVISION SURGERY PERFORMED. THE NAIL WAS REMOVED AND REPLACED WITH A LONGER NAIL.

  Patient problems: Arthralgia; Failure of Implant; Pain

  MAUDE report 11362164 ↗
• InjurySep 27, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THEY PERFORMED THE REDUCTION OF THE FRACTURE, STEP BY STEP IN ORDER TO DO THE PREPARATION OF THE SPINAL CANAL, AN INTERTAN NAIL 11.5X18CM 125 ° WAS PASSED TO THE TABLE AND THIS WAS IMPLANTED IN THE PATIENT, THE RESPECTIVE STEPS WERE FOLLOWED FOR PLACEMENT THE KIT SCREWS THAT GO TO THE FEMORAL HEAD. SYSTEM WAS BLOCKED WITH THE RESPECTIVE PIECE TO SLIDE THE LOCKING BOLT BUT IN X-RAYS IT WAS EVIDENCED THAT IT DID NOT BLOCK, DUE TO THIS THE KIT SCREWS AND THE NAIL WERE REMOVED AND A NEW NAIL WAS NECESSARY BECAUSE THERE WAS NO OTHER NAIL IN THE INSTITUTION OR AT THE TIME. BY DECISION OF THE SPECIALIST, A NAIL 10SX18CM 125° WAS PLACED THAT IS, A SMALLER DIAMETER THAN THE ONE PREVIOUSLY DECIDED TO BE PLACED. THIS WAS PREVIOUSLY VERIFIED BEFORE IMPLANTING IT IN THE PATIENT, EVIDENCING THE PRESENCE OF THE LOCKING BOLT, THE NAIL WAS PASSED INTO THE PATIENT AND THE RESPECTIVE STEPS WERE AGAIN CARRIED OUT FOR THE PLACEMENT OF THE SCREWS AND THE LOCKING OF THE SYSTEM. THE 11.5X18CM 125 ° INTERTAN NAIL WAS CHECKED ON THE SURGICAL TABLE AND IT WAS EVIDENT THAT THE LOCKING BOLT WAS NOT FOUND. NO DELAY WAS REPORTED.

  Patient problems: Injury

  MAUDE report 9131482 ↗
• MalfunctionFeb 24, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY THE DRILL INTERFERED WITH THE NAIL, THE DISTAL SCREW COULD NOT BE HOLD INTO PLACE, RESULTING IN USING OTHER LENGTH SCREW. PROCEDURE WAS COMPLETED FREE HANDS. DELAY FROM (0 - 30) MINUTES REPORTED. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364847 ↗
• InjurySep 6, 2018Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED A SERIOUS INJURY IN WHICH A REVISION SURGERY WAS PERFORMED DUE TO NAIL CUTOUT.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7850282 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH CLINICAL TRIAL THAT PATIENT'S HOSPITALISATION WAS INITIATED/ EXTENDED AND THAT MEDICATION THERAPY WAS ADMINISTERED DUE TO PULMONARY EMBOLISM. SEVERITY WAS DEEMED AS MODERATE AND THIS EVENT WAS MARKED AS PROCEDURE POSSIBLY RELATED, DEVICE NON-RELATED. PATIENT IS RECOVERING.

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 6713308 ↗
• InjuryMay 11, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PROXIMAL PART OF THE NAIL WAS TO LONG COMPARED TO THE SIZE OF THE PATIENT. THE SURGEON REQUESTS TO MAKE THE PROXIMAL PART SHORTER IN ORDER TO USE FOR SMALL PATIENTS. IT WAS A PRIMARY OPERATION. THE SURGEON COMPLETED THE OPERATION WITH ANOTHER NAIL OF SMALLER SIZE, HOWEVER THE SURGERY TOOK 30 TO 60 MINUTES.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6559635 ↗

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,