TRIGEN 71674068Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 03596010560612), received between Apr 22, 2017 and Feb 2, 2026 — classified as 19 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Break” (79 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 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADS OF ONE (1) SUBTROC LAG SCREW DRIVER BROKE WHILE COMPRESSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240327 ↗
• MalfunctionJan 6, 2026Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING AN INTRENAL FIXATION SURGERY, WHEN THE SURGEON WAS TRYING TO REMOVE A SUBTROCH LAG SCREW TO REPLACE IT WITH A DIFFERENT ONE; UPON TRYING TO TURN THE SCREW OUT, THE TIP OF ONE (1) SUBTROC LAG SCREW DRIVER SNAPPED OFF WITHIN THE LAG SCREW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N -BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977849 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERTAN SURGERY, ONE (1) SUBTROC LAG SCREW DRIVER BROKE WHILE COMPRESSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768012 ↗
• MalfunctionOct 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAIL EXTRACTION SURGERY, THE TIP OF ONE (1) SUBTROC LAG SCREW DRIVER WAS SNAPPED OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335844 ↗
• MalfunctionAug 26, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN COMPRESSING THE CEPHALIC SCREW, ONE (1) SUBTROC LAG SCREW DRIVER BROKE. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901219 ↗
• MalfunctionAug 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, WHEN REMOVING THE SUBTROC LAG SCREW DRIVER, THE THREAD OF THE FASTENER BROKE, NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801521 ↗
• MalfunctionJul 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY THE PIN OF ONE (1) SUBTROC LAG SCREW DRIVER BROKE CAUSING IT TO NO LONGER HOLD THE SCREW. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552232 ↗
• MalfunctionMay 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE SUBTROC LAG SCREW DRIVER SHAFT THREADED BROKE WHILE TIGHTENING ONTO THE LAG SCREW. THE PROCEDURE WAS COMPLETED WITHOUT 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 22002980 ↗
• MalfunctionFeb 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A LEFT HIP INTERTROCHANTERIC FRACTURE SURGERY, THE THREADS FROM THE TIP OF ONE (1) SUBTROC LAG SCREW DRIVER WHICH CONNECTS THE HANDLE TO THE LAG SCREW BROKE OFF UPON FINAL TIGHTENING, AND REMAINED INSIDE THE PATIENT. THE SURGEON MADE A LARGER INCISION AND REMOVE THE BROKEN TIP OF THE SUBTROC LAG SCREW DRIVER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21493580 ↗
• MalfunctionJan 31, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADS ON ONE [1] SUBTROC LAG SCREW DRIVER SNAPPED WHILE BEING USED. 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. THE BROKEN PIECE WAS RETRIEVED AND ACCOUNTED FOR USING A PITUITARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284057 ↗
• MalfunctionJan 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OSTEOSYNTHESIS SURGERY, WHEN THE SUBTROCHANTERIC SCREW WAS BEING CAPTURED WITH THE SUBTROC LAG SCREW DRIVER, THE THREAD OF THE SUBTROC LAG SCREW DRIVER BROKE, BUT THE THREAD WAS COMPLETELY REMOVED. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091978 ↗
• MalfunctionDec 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION, THE THREADS OF INNER CAPTURE OF ONE (1) SUBTROC LAG SCREW DRIVER BROKE WHILE COMPRESSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859336 ↗
• MalfunctionOct 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE TIP OF THE SUBTROC LAG SCREW DRIVER BROKE OFF DUE TO EXCESSIVE WEAR AND TEAR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446391 ↗
• InjurySep 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A HIP INTERNAL FIXATION, THE SUBTROC LAG SCREW DRIVER FRACTURED DURING COMPRESSION OF THE CEPHALIC SCREW. THE THREADED PORTION REMAINED FIXED TO THE CEPHALIC SCREW THAT WAS IMPLANTED IN THE PATIENT, THE OTHER PIECES WERE REMOVED .THE PROCEDURE WAS PERFORMED, AFTER NO DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20165919 ↗
• MalfunctionJul 22, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, A TRIGEN INTERTAN SUBTROCHANTERIC LAG SCREW 11MM X 75MM WAS GOING TO BE IMPLANTED FOR PROXIMAL LOCKING BUT AT THE TIME OF MAKING THE ASSEMBLY OF THE SCREW IT WAS NOTICED THAT THE SUBTROC LAG SCREW DRIVER HAD NO THREADS, SO IT WAS NOT POSSIBLE TO PLACE THE IMPLANT. AFTER A NON-SIGNIFICANT DELAY, IN ORDER TO SOLVE THE PROBLEM AND TO BLOCK THE PROXIMAL NAIL AN INTERTAN LAG/COMPRESSION SCREW KIT 95MM / 90MM WAS USED INSTEAD. FOR THIS, A SECOND BONE HOLE BECAME NECESSARY TO INSERT THE INTEGRATED SCREW. IT WAS IN THIS WAY THAT THE PROXIMAL LOCKING OF THE NAIL WAS ACHIEVED. NO OTHER INJURIES WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19801075 ↗
• MalfunctionJul 2, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, THE CAPTURE THREADS OF THE SUBTROC LAG SCREW DRIVER BROKE DURING TIGHTENING. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662117 ↗
• MalfunctionMay 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERTAN NAIL PLANNED REMOVAL SURGERY, THE TIP OF THE SUBTROC LAG SCREW DRIVER BROKE WHILE REMOVING THE LAG SCREW. NO PIECES FELL IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19408186 ↗
• MalfunctionMay 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE SUBTROC LAG SCREW DRIVER DEVICE BROKE OFF FROM SCREW. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293501 ↗
• MalfunctionFeb 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A HARDWARE REMOVAL ON AN INTERTAN NAIL, WHEN TRYING TO PUT THE SUBTROC LAG SCREW DRIVER ON THE SCREW, THE RETENTION ROD FRACTURED AT THE THREADED TIP, NO PIECES FELL INTO 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 18665134 ↗
• MalfunctionFeb 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A HARDWARE REMOVAL OF AN INTERTAN NAIL, IT WAS OPENED ANOTHER SET AND WHEN TRYING TO PUT THE SUBTROC LAG SCREW DRIVER ON THE SCREW, THE RETENTION ROD FRACTURED AT THE THREADED TIP, NO PIECES FELL INTO 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 18665120 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADED PORTION OF THE SUBTROC LAG SCREW DRIVER RETAINING ROD BROKE OFF. THIS OCCURRED WHILE IN THE IMPLANT, AS IT WAS BEING TIGHTENED DOWN AND ONCE ROTATIONAL TORQUE WAS APPLIED IS WHEN THE PIECE SNAPPED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO PIECES FELL INTO THE PATIENT, NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18033496 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A HARDWARE REMOVAL SURGERY, THE INTERNAL THREADED CAPTURE BAR, THAT SCREWS INTO THE LAG SCREW, OF ONE (X1) SUBTROC LAG SCREW DRIVER BROKE WHILE TRYING TO REMOVE A LAG SCREW. NO PIECES FELL INSIDE OF THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED, AFTER A DELAY GREATER THAN 30MINS, WITH A COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887362 ↗
• MalfunctionAug 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADED END OF A SUBTROC LAG SCREW DRIVER BROKE OFF DUE TO OVER TENSION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643205 ↗
• MalfunctionAug 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE CAPTURE PIECE OF A SUBTROC LAG SCREW DRIVER BROKE WHEN THE SURGEON WAS TIGHTENING THE LAG SCREW. THE BROKEN PIECE WAS SUCTIONED OUT OF THE PATIENT AND ACCOUNTED FOR. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592024 ↗
• MalfunctionAug 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, WHILE IMPLANTING DURING A NAIL CASE, ONE (1) SUBTROC LAG SCREW DRIVER TIP BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553549 ↗

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