TRIGEN 71675385Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556343647), received between Apr 27, 2021 and Apr 5, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2026Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A DISTAL BREAK ON ONE (1) INTERTAN 10S 10MM X 20CM 125D. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE NAIL WAS REVISED. CURRENT HEALTH STATUS OF PATIENT REMAIN UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24786993 ↗
• InjuryJul 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN ORIF SURGERY THAT HAD BEEN PERFORMED ON THE (B)(6) 2025, ONE (1) INTERTAN 10S 10MM X 20CM 125D BROKE INSIDE THE PATIENT IN THE DISTAL LOCKING SCREW APERTURE ON THE (B)(6) 2025. THE PATIENT WAS ATTEMPTING TO GET INTO THE BED AND FELT A POP, AND IT HAD A SUDDEN ONSET PAIN IN THE PROXIMAL THIGH AREA. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE DEVICE WAS REPLACED WITH A LONG TRIGEN INTERTAN NAIL. THE PATIENT TOLERATED THE PROCEDURE WELL, AND IT WAS ABLE TO BEAR WEIGHT AND HIS PAIN IS UNDER CONTROL.

  Patient problems: Failure of Implant; Hip Fracture; Loss of fracture reduction; Periprosthetic fracture

  MAUDE report 22374041 ↗
• InjuryMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A SUDDEN POP AND PAIN AT 6 WEEKS POST-OP, NO ADDITIONAL FALL. ON (B)(6) 2025 AN X-RAY CONFIRMS THE FRACTURE OF THE NAIL AT THE DISTAL SCREW HOLE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE INTERTAN 10S 10MM X 20CM 125D WAS REMOVED. PATIENT'S CURRENT HEALTH STATUS IS STABLE AND RECOVERING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 21693464 ↗
• InjuryJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A DISTAL FRACTURE OF ONE (1) INTERTAN 11.5MM X 20CM 125D. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE DEVICE WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Pain; Periprosthetic fracture

  MAUDE report 21063898 ↗
• InjuryDec 10, 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 PROCEDURE PERFORMED ON (B)(6) 2020 TO TREAT AN INTERTROCHANTERIC HIP FRACTURE, THE PATIENT SUSTAINED AN UNSPECIFIED PERIPROSTHETIC FRACTURE ON THE SECOND POSTOPERATIVE DAY AND REQUIRED NAIL REVISION. 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: Periprosthetic fracture

  MAUDE report 20896413 ↗
• InjurySep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO A SUBTROCHANTERIC FEMUR FRACTURE, THE PATIENT PRESENTED WITH A FRACTURE OF AN INTERTAN 10S 10MM X 20CM 125D. THE BROKEN NAIL DID NOT RESULT IN A FRACTURE OF THE BONE. IT WAS MENTIONED THAT THE PATIENT HAD AN UNOBSERVED FALL AT HOME. TO ADDRESS THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE PREVIOUS IMPLANTS AND THEIR COMPONENTS WERE REMOVED AND REPLACED WITH A S+N NAIL 11.5MM X 34 CM, 125°, AND INTEGRATED INTERLOCKING SCREWS 95/90MM. THE PATIENT¿S CURRENT HEALTH STATUS IS IN REMISSION, AND PARTIAL WEIGHT BEARING OF 20 KG IS ALLOWED.

  Patient problems: Failure of Implant; Fall

  MAUDE report 20227495 ↗
• InjuryAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN ORIF SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE LAST YEAR, THE PATIENT PRESUMABLY HAD A NON-UNION WHICH CAUSED ONE (1) INTERTAN 10S 10MM X 20CM 125D TO BREAK AT THE JUNCTION OF THE LAG AND COMPRESSION SCREWS CAUSING SUDDEN PAIN ALONG HER HIP. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH ALL BROKEN PIECES FROM THE INTERTAN NAIL WERE REMOVED AND CONVERTED TO A THR. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20033726 ↗
• InjuryFeb 13, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A INTERTAN NAIL PROCEDURE ON LEFT SIDE, THE NAIL INTERTAN 10S 10MM X 20CM 125D WAS INSERTED AND REMOVED IN THE PATIENT THREE TIMES AND EXTRA REAMING OF THE FEMORAL CANAL, DUE TO DIFFICULTY INSERTING. THE PATIENT WAS ALSO REPOSITIONED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME IMPLANT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18695323 ↗
• InjuryMar 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TRAUMA NAILING SURGERY, ONE (1) INTERTAN 10S 10MM X 20CM 125D BROKE AT THE DISTAL LOCKING SCREW. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2023 TO ADDRESS THE ISSUE. PATIENT CURRENT HEALTH STATUS IS ESTABLE

  Patient problems: Failure of Implant

  MAUDE report 16527340 ↗
• InjuryFeb 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A RIGHT FEMORAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE INTERTAN 10S 10MM X 20CM 125D BROKE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE DEVICE WAS REPLACED AND ALL PIECES OF THE NAIL WERE REMOVED, USING TRIGEN NAIL REMOVAL SET. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 16327147 ↗
• InjuryNov 5, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S RIGHT FEMUR ON (B)(6) 2018 TO TREAT AN INTERTROCHANTERIC FRACTURE, THE PATIENT SUSTAINED A PERI-IMPLANT FRACTURE AND THE BREAKAGE OF THE PROSTHESIS AS A CONSEQUENCE OF A FALL TWELVE (12) WEEKS POSTOPERATIVELY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO TREAT THIS ISSUE. THE IDENTITY OF THE PROSTHESIS IMPLANTED IN EXCHANGE REMAINS UNKNOWN. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Hip Fracture

  MAUDE report 15741085 ↗
• InjuryNov 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2018 TO TREAT A PERTROCHANTERIC FRACTURE, THE PATIENT SUSTAINED A NEW DISPLACED PERIPROSTHETIC FEMORAL NECK FRACTURE AROUND THE COMPRESSION PROXIMAL SCREW KIT WITH PROTRUSION OF THE SCREW KIT BEYOND THE FEMORAL HEAD. NO ACETABULAR EROSION WAS NOTED AS A CONSEQUENCE OF THIS COMPLICATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. THE IDENTITY OF THE PROSTHESIS IMPLANTED IN EXCHANGE IS NOT KNOWN. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 15741083 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S RIGHT FEMUR ON (B)(6) 2020 TO TREAT AN UNSPECIFIED HIP FRACTURE, THE PATIENT SUSTAINED A GROUND LEVEL FALL WITH A PERIPROSTHETIC MIDSHAFT FEMORAL FRACTURE AT THE TIP OF THE NAIL. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. ANY ADDITIONAL DETAILS REGARDING THIS INTERVENTION WERE NOT PROVIDED, AND THE PATIENT'S OUTCOME REMAINS ALSO UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 15459910 ↗
• InjuryJul 21, 2022Migration; Migration

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY, THE TRIGEN INTERTAN 10S 10MM X 20CM 125DEGREE WAS BACKING OUT OF THE PATIENTS FEMUR AND BEGAN TO FAIL. THIS SITUATION WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE SYSTEM AND REPLACE IT WITH A THR. PATIENT IS RECOVERING FROM THE SURGERY AS PER NORMAL.

  Patient problems: Failure of Implant

  MAUDE report 15072243 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT A INTERTAN 10S 10MM X 20CM 125D BROKE. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14018440 ↗
• InjuryJan 20, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A NAILING SURGERY HAD BEEN PERFORMED, AN INTERTAN 10S 10MM X 20CM 125D BROKE DOWN BY THE DISTAL 5.0 SCREW SLOT. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE BROKEN NAIL. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13310778 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO INSERT A SHORT INTERTAN (INTERTAN 10S 10MM X 20CM 125D) ON (B)(6) 2021; ON (B)(6) 2021 THE BONE BELOW THE FRACTURE WAS FOUND TO BE BROKEN. A NEW SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGE THE SHORT INTERTAN (INTERTAN 10S 10MM X 20CM 125D) FOR A LONG VERSION.

  Patient problems: Bone Fracture(s)

  MAUDE report 12144709 ↗
• InjuryApr 27, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY HAD BEEN PERFORMED, THE INTERTAN 10S 10MM X 20CM 125D NAIL BROKE INSIDE A PATIENT, CAUSING PAIN AND LACK OF MOBILITY. ON X-RAYS THE BROKEN NAIL COULD NOT BE SEEN. A REVISION SURGERY WAS PLAN TO REMOVE IT AND SWITCH TO BIPOLAR DUE TO THE PAIN THE PATIENT WAS EXPERIENCING. IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 11735181 ↗

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-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