TRIGEN 71674087Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03596010580443), received between Feb 11, 2019 and May 18, 2026 — classified as 5 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (20 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADS OF ONE (1) LAG DRIVER RETAINING ROD ASSEMBLY BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209307 ↗
• MalfunctionMay 18, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A LAG DRIVER RETAINING ROD ASSY SNAPPED OFF. AS THE ROD WAS THREAD INTO THE LAG SCREW, THE TIP REMAINED IN THE SCREW AND DETACHED FROM THE ROAD. NO HARM TO PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204427 ↗
• MalfunctionApr 6, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY UPON REMOVAL, THE LAG DRIVER RETAINING ROD ASSY DID NOT RELEASE, AND WHEN THE LITTLE MARTIAN IS ASSEMBLED, THE PROXIMAL PART PEELS OFF AND FRACTURED. NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING ROCHESTER FORCEPS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794617 ↗
• MalfunctionSep 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING NAIL REMOVAL CASE, CAPTURE THREADS OF ONE (1) LAG DRIVER RETAINING ROD ASSY BROKE TRYING TO REMOVE A NAIL. NO BROKEN PIECES FELL INTO THE PATIENT. 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 23100297 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY THE THREADS OF TWO (2) LAG DRIVER RETAINING ROD ASSY WERE BROKEN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085740 ↗
• MalfunctionJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP THAT GOES INSIDE THE PATIENT OF ONE (1) LAG DRIVER RETAINING ROD ASSY BROKE OFF. IT WAS WHILE BEING USED WITH THE PATIENT, BUT THE TIP OF THE ROD WAS SCREWED INTO THE LAG SCREW, SO NO PART OF THE INSTRUMENT FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22185663 ↗
• MalfunctionJan 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, A LAG DRIVER RETAINING ROD ASSY BROKE AT THE WRENCH END OF THE ROD. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208176 ↗
• MalfunctionMar 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION REVISION SURGERY, IN THE PROCESS OF NAIL EXTRACTION, TWO (2) LAG DRIVER RETAINING ROD ASSEMBLIES BROKE. IT IS UNCERTAIN IF PIECES FELL INTO PATIENT'S ANATOMY. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928890 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, THE THREADED TIP OF A LAG DRIVER RETAINING ROD ASSY BROKE DURING INTERTAN REMOVAL CASE. ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH THE SAME DEVICE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857121 ↗
• InjuryFeb 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING NAIL SURGERY, THE TIP OF ONE (1) LAG DRIVER RETAINING ROD ASSEMBLY BROKE OFF WHEN THE SCREW WAS FINISHED BEING DRIVEN IN. THE TIP WAS LEFT IN THE SCREW BECAUSE THE SCREW WAS SCREWED IN ALL THE WAY AND THE BREAK WAS FLUSH WITH THE SCREW HEAD. THE SURGEON CONSIDERED THERE WAS NO ELEVATED RISK ON LEAVING THE BROKEN TIP INSIDE THE PATIENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16301739 ↗
• MalfunctionNov 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE TIP OF THE THREAD OF THE LAG DRIVER RETAINING ROD ASSY HAS BROKEN OFF AND GOT JAMMED IN THE LAG SCREW DURING REMOVAL. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN S+N BACK BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714979 ↗
• MalfunctionOct 26, 2022Break; Break

  IT WAS REPORTED THAT A TIP OF A LAG DRIVER RETAINING ROD ASSY WAS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675080 ↗
• InjuryAug 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAIL REMOVAL PROCEDURE, THE THREADED END OF A LAG DRIVER RETAINING ROD ASSY BROKE OFF WHEN REMOVING THE LAG SCREW. THE TREADS AND SCREW WERE REMOVED USING PLIERS. SURGERY WAS PERFORMED, WITH A NON-SIGNIFICANT DELAY, BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED BEYOND THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282138 ↗
• MalfunctionMar 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE LAG DRIVER RETAINING ROD ASSY BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED DUE TO THIS ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791959 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT A LAG DRIVER RETAINING ROD ASSY IS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365441 ↗
• MalfunctionJan 19, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A META-TAN LAG SCREW DRIVER IS STRIPPED AND BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13293758 ↗
• MalfunctionDec 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT, A LAG DRIVER RETAINING ROD ASSY RETAINING ROD WOULD NOT THREAD AND IS CHIPPED. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011025 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED, THAT THE THREADED END OF A LAG DRIVER RETAINING ROD ASSY BROKE OUTSIDE THE PATIENT. SURGERY WAS COMPLETED, WITHOUT SIGNIFICANT DELAY, BY USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524147 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE TIP OF A LAG DRIVER RETAINING ROD ASSY WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. THIS PROBLEM CAUSED A SURGICAL DELAY OF 30 MINUTES OR LESS. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303999 ↗
• MalfunctionJul 29, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING A INTERNAL FIXATION SURGERY, THE TIP OF LAG DRIVER RETAINING ROD ASSY WHICH SCREWS ONTO THE INTERNAL CAPTURE SCREWS BROKE. IN ADDITION, THE OPPOSITE END WHICH TIGHTENS THE LAG DRIVER RETAINING ROD ASSY INTO THE SCREW, DEFORMED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250180 ↗
• MalfunctionMay 31, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY WHILE THE INSTRUMENTS WERE INSIDE OF THE PATIENT, THE LAG SCREW DRIVER (B)(4) CAPTURE STICK CAUGHT ONTO A GUIDE PIN AND SEEMED TO BE DEFECTIVE; THE PIECE ON THE T-HANDLE (B)(4) WAS BROKEN IN THE CAPTURES OF THE SCREWDRIVER. THERE WERE NO PIECES BROKEN OFF INSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909918 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT DURING STERILE SERVICES IT WAS NOTICED THAT THE BALL BEARING OF THE INTERTAN 3.2MM GUIDE PIN SLEEVE WAS MISSING. ADDITIONALLY, THE LAG DRIVER RETAINING ROD ASSY HAS THE END DAMAGED. NO CASE INVOLVED. AFTER PRODUCT EVALUATION IT WAS DETERMINED THAT THE DEVICE HAS DAMAGED/CHIPPED THREADS, RENDERING IT INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772715 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT, A LAG DRIVER RETAINING ROD ASSY BROKE DURING HIP FRACTURE SURGERY. INSTRUMENT WAS OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30 MIN DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742452 ↗
• MalfunctionMar 25, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE END OF THE LAG DRIVER RETAINING ROD ASSY IS BENT, WAS NOTICED BEFORE ITEM WAS USED IN PROCEDURE. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572308 ↗
• MalfunctionMar 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER AN UNSPECIFIED PROCEDURE IT WAS NOTICED THAT THE LAG DRIVER RETAINING ROD ASSY WAS BENT. PROCEDURE FINISHED WITH SAME DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha