TRIGEN 71675384Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556105740), received between Jul 31, 2019 and Jan 26, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) INTERTAN 10S 10MM X 18CM 130D AS OPENED AND INSERTED SUCCESSFULLY. HOWEVER, DURING THE LOCKING PHASE, THE LEG SCREW REPEATEDLY HIT THE REPORTED DEVICE, CAUSING BENDING AND STRIPPING. THE REPORTED DEVICE WAS REMOVED AND TESTED OUTSIDE THE PATIENT WITH THE SCREWS AND ANTI ROTATION SLEEVE. ALTHOUGH IT APPEARED FUNCTIONAL EXTERNALLY, THE SCREW CONTINUED TO HIT THE REPORTED DEVICE. THE IMPLANT WAS THEN CHANGED TO A 125 DEGREE, 10 MM × 18 CM NAIL, AFTER WHICH THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP. THE PROCEDURE REQUIRED ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177296 ↗
• 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 SURGERY PERFORMED ON (B)(6) 2021 TO TREAT A DISPLACED INTERTROCHANTERIC FRACTURE OF THE FEMUR, THE PATIENT REQUIRED A CONVERSION TO THR ON (B)(6) 2021 DUE TO WORSENING OF PAIN WITH ACTIVITY AND WEIGHT BEARING, TRENDELENBERG GAIT AND PASSIVE RANGE OF MOTION. PATIENT HAD EVIDENCE OF FAILED IM NAIL SURGERY BY IMAGING STUDIES. 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: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 20896248 ↗
• MalfunctionNov 13, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILE PACKAGING OF A INTERTAN 10S 10MM X 18CM 130D WASN'T SEALED ON ONE SIDE, THEREFORE IT WAS CONSIDERED NON-STERILE AND DISCARDED. THERE WAS A NON-SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673836 ↗
• MalfunctionDec 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING NAIL FIXATION SURGERY WHEN CHECKING THE ALIGNMENT OUTSIDE THE PATIENT AND THE INTERTAN 10S 10MM X 18CM 130D NAIL WAS CONNECTED TO THE 130D GUIDE, THE LAG SCREW DRILL WAS ATTEMPTED TO TARGET/PASS THE NAIL HOLE, BUT IT WAS NOT POSSIBLE BECAUSE THE TIP OF THE LAG SCREW DRILL HIT THE NAIL. AFTER CHANGING THE GUIDE FROM 130D TO 125D, THE DRILL TARGETED/PASSED THE NAIL HOLE AND IT WAS CONFIRMED THAT THE MENTIONED NAIL DOES NOT HAVE A 130D NECK ANGLE, BUT A 125D NECK ANGLE. THE LASER MARKING ON THE NAIL AND THE PART NUMBER ON THE INNER/OUTER LABEL IS 71675384(130D). SURGERY WAS COMPLETED, AFTER A DELAY OF 5 MINUTES, BY IMPLANTING AN INTERTAN 11.5MM X 18CM 130D NAIL INSTEAD. HOWEVER, AS THERE WAS SPACE, ADDITIONAL REAMING WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270606 ↗
• InjuryAug 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY PERFORMED ABOUT 10 MONTHS AGO, THE PATIENT EXPERIENCED A FRACTURE (PRESENTS AS A NON-UNION). A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO SOLVE THIS ISSUE AND IT WAS CONVERTED TO A TKA. X-RAYS WERE PROVIDED AND IT SEEMS THAT THE NAIL AND THE SCREW WERE FRACTURE. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15332363 ↗
• 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 12396068 ↗
• MalfunctionMar 9, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, WHILE DRILLING, A COMPRESSION SCREW DID NOT TARGET THE SCREW HOLE ON THE NAIL. THEN REMOVING THE NAIL AND CHECKING, IT WAS FOUND THERE WAS DAMAGE AROUND THE SCREW HOLE. USING A SMITH AND NEPHEW BACK UP DEVICE, THE SURGERY WAS COMPLETED. NO HARM TO PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449200 ↗
• 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 9528702 ↗
• InjuryNov 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT PRIMARY SUGERY WAS PERFORMED ON (B)(6) 2019. PATIENT SUFFERED A PSEUDOARTHROSIS AND NAIL HAD TO BE REMOVED. DURING THE REMOVAL OF THE DEVICE, THE PHYSICIAN REALIZED THE NAIL WAS BROKEN. THE DEVICE AND ALL THE PIECES WERE REMOVED FROM THE PATIENT AND ANOTHER INTERTAN NAIL WITH A DIFFERENT SIZES WAS PLACED. THE PROCEDURE WAS BEING PERFORMED WAS THE RIGHT HIP OSTEOSYNTHESIS. THE PATIENT IS STABLE WITHOUT ANY DAMAGE SINCE ALL THE PIECES WERE REMOVED. ANOTHER OF THE SAME DEVICE WAS USED IN ORDER TO COMPLETE THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 9284405 ↗
• MalfunctionJul 31, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SURGERY, THE NAIL USED WAS LABELED AS A 130 DEGREE NAIL BUT IT WAS ACTUALLY A 125 DEGREE NAIL. THE NAIL WAS INSERTED INTO PATIENT AND DRILLED WHEN DOCTOR REALIZED SOMETHING DIDN'T SEEM RIGHT. DOCTOR ATTEMPTED TO INSERT THE LAG SCREW WITH NO SUCCESS. THE NAIL WAS REMOVED. CORRECT NAIL WAS THEN INSERTED INTO PATIENT WITHOUT ANY ISSUES OR CONCERNS. NO INJURY OR HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8847315 ↗

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