TRIGEN 71674067Recalls & reported problems

Summary

The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 03596010560605), received between Sep 29, 2017 and May 15, 2026 — classified as 19 injuries, 182 malfunctions.

The most frequently reported specific device problem is “Break” (104 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 201 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT, DURING NAIL, ONE (1) LAG SCREW DRIVER TIP WAS BROKEN IN USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185420 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE CAPTURE PIECE OF ONE (1) LAG SCREW DRIVER BROKE. 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 24897573 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY (INTERTROCHANTERIC NAILING), A LAG SCREW DRIVER BROKE. NO PIECES WERE INSIDE THE PATIENT, THE PIECES WERE COUNTED. THE PROCEDURE WAS RESUMED, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF A DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750388 ↗
• MalfunctionMar 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A NAIL REMOVAL SURGERY, THE THREADED TIP OF A LAG SCREW DRIVER BROKE OFF INTO THE LAG SCREW. THE PROCEDURE WAS PERFORMED, 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 24690807 ↗
• InjuryMar 2, 2026Fracture

  IT WAS REPORTED THAT, DURING NAIL EXTRACTION SURGERY, THE DISTAL TIP OF ONE (1) SHORT HEXDRIVER SHOWED SIGNS OF WEAR AND SLIPPED ON THE SCREW HEAD. ALSO, THE DISTAL TIP OF ONE (1) LAG SCREWDRIVER BROKE WHEN THEY WANTED TO REMOVE THE SCREW. THE TIP WAS REMOVED WITH A CLAMP, AND THE WOUND WAS WASHED CAREFULLY. ADDITIONALLY, THE OR FOUND THAT ONE (1) RULER WAS BROKEN, THEN IT WAS NOT USED IN THE SURGERY. ALL DEBRIS WAS REMOVED FROM THE WOUND. THE SCREW WAS VERY TIGHT AND COVERED WITH BONE CALCIFICATION, THEN IT WAS UNABLE TO REMOVE IT. THE SURGEON TRANSFERRED THE PATIENT TO ANOTHER HOSPITAL. IT IS UNCLEAR WHETHER THERE WAS ANY DELAY OR HOW THE PROCEDURE CONCLUDED PRIOR TO THE PATIENT¿S TRANSFER. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24483291 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A IMN FEMUR SURGERY, THE THREADS OF ONE (1) LAG SCREW DRIVER BROKE DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638433 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, THE END OF INTERNAL CAPTURE OF ONE (1) LAG SCREW DRIVER WAS BROKEN. 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 21896320 ↗
• MalfunctionApr 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, THE THREADS OF CAPTURE ROD OF THE LAG SCREW DRIVER BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, 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 21813335 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE GRIP ON THE CAPTURE ROD OF A (1) LAG SCREW DRIVER SNAPPED OFF. 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 21628156 ↗
• MalfunctionFeb 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RETAINING ROD ON ONE (1) LAG SCREW DRIVER BROKE INTO TWO PIECES. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304094 ↗
• MalfunctionDec 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE TIP OF A LAG SCREW DRIVER BROKE OFF WHEN REMOVING LAG SCREW. 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 20995742 ↗
• MalfunctionDec 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, ONE (1) LAG SCREW DRIVER BROKE. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE, IT IS UNKNOWN IF THERE WAS ANY DELAY. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851201 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF REVISION SURGERY, ONE (1) LAG SCREW DRIVER FRACTURED WHEN TRYING TO THREAD THE DRIVER ONTO THE LAG SCREW. THE BROKEN PIECE WAS ACCOUNTED FOR IMMEDIATELY. IT WAS STILL ATTACHED TO THE DRIVER WHEN IT HAPPENED, SO IT CAME OFF AND DIDN¿T NEED TO BE RETRIEVED. THIS OCCURRED AT A COMPLEX BROKEN COMPRESSION SCREW REMOVAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613374 ↗
• MalfunctionAug 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING ORIF SURGERY, THE TIP OF ONE (1) LAG SCREW DRIVER FRACTURED. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958111 ↗
• MalfunctionAug 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE THREAD PART OF THE CAPTURE PIECE OF ONE (1) LAG SCREW DRIVER BROKE WHILE TIGHTENING THE SCREW. 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 19956251 ↗
• MalfunctionAug 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE REMOVING THE LAG SCREW, THE CAPTURE PIECE OF A LAG SCREW DRIVER WAS SNAPPED INTO TWO PIECES. NO 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 19906983 ↗
• MalfunctionJul 23, 2024Fracture; Material Twisted/Bent; Mechanics Altered; Fracture; Material Twisted/Bent; Mechanics Altered

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHILE TIGHTENING THE LAG SCREW DRIVER TO THE HANDLE, THE THIN, INNER CAPTURE SLEEVE WOULD NOT LOCK DOWN INTO THE SCREW. FURTHERMORE, WHILE DETACHING THE LAG SCREW HANDLE FROM THE INSERTED LAG SCREW, IT WAS NOTICED THAT THE MOST PROXIMAL PART, WHERE THE WRENCH TIGHTENS THE SCREW DOWN, WAS STRIPPED, GOT BROKEN OFF AND COULD NOT BE FOUND. IN ADDITION, SURGICAL RING FORCEPS WERE NEEDED TO TAKE APART THE INNER CAPTURE AND LEG SCREW HANDLE FROM THE INSERTED LAG SCREW. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED OR IF ANY DELAY OCCURRED. NO FURTHER CONSEQUENCES WERE REPORTED. THERE WAS NO PART OF THE INSTRUMENT THAT WAS RETAINED IN THE PATIENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807201 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) LAG SCREW DRIVER BROKE OFF WHEN ATTEMPTING TO REMOVE A SCREW. IT IS UNKNOWN IF BROKEN PIECES FELL INTO THE PATIENT, AND HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19523220 ↗
• MalfunctionMay 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE BACK OF RETAINING ROD OF THE LAG SCREW DRIVER SHEARED SO THE WRENCH CANT ENGAGE IT. 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 19400819 ↗
• MalfunctionApr 22, 2024Fracture; Mechanics Altered; Fracture; Mechanics Altered

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE LAG SCREW DRIVER HAS PHYSICALLY BROKEN IN USE AND NO LONGER ENGAGES SCREW. 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 19156387 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, WHILE TRYING TO RELEASE A SCREW DURING A NAIL PROCEDURE, THE CAPTURE FROM ONE (1) LAG SCREW DRIVER HAD THE FLANGES BREAK OFF WHICH MADE IT UNABLE TO RELEASE THE SCREW BENDING THE SCREWDRIVER RELEASE HANDLE. NO PIECED FELL INTO 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 18856570 ↗
• MalfunctionFeb 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING NAIL PROCEDURE THE INTERNAL CAPTURE TIP BROKE OFF THE LAG SCREW DRIVER. NO PIECES FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684530 ↗
• MalfunctionDec 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING NAIL REMOVAL, A LAG SCREW DRIVER CAPTURE TIP WAS BROKEN. IT IS UNKNOWN IF IT FELL INTO THE PATIENT, BUT THE BROKEN PART WAS RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418725 ↗
• MalfunctionDec 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING LAG SCREW PLANNED REMOVAL, TWO (2) LAG SCREW DRIVERS WERE BROKEN OFF AT THE DISTAL THREADED TIP, TRYING TO EXTRACT THE LAG SCREW. 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 18394936 ↗
• MalfunctionDec 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING LAG SCREW PLANNED REMOVAL, TWO (2) LAG SCREW DRIVERS WERE BROKEN OFF AT THE DISTAL THREADED TIP, TRYING TO EXTRACT THE LAG SCREW. 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 18394934 ↗

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