TRIGEN 71674079Recalls & reported problems

Summary

The FDA's MAUDE database contains 454 adverse event reports that list this exact device (DI 03596010560759), received between Feb 5, 2018 and Jun 15, 2026 — classified as 16 injuries, 438 malfunctions.

The most frequently reported specific device problem is “Break” (392 reports).

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 454 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Fracture

  IT WAS REPORTED THAT, DURING A ORIF SURGERY, THE THREADS OF ONE (1) RULER CHIPPED OFF. 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 25498087 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) RULER HAD A BROKEN BLACK PLASTIC COMPONENT. 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 25024805 ↗
• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT, DURING A TRIGEN IM NAILING SURGERY, THE OUTER SLEEVE OF ONE (1) RULER SNAPPED AT THE CONNECTION TO THE INNER SLEEVE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541655 ↗
• MalfunctionFeb 14, 2026Fracture

  IT WAS REPORTED THAT DURING A NAIL PROCEDURE, THE RULER TIP HAS SNAPPED OF THE END OF IT MAKING IT UNUSABLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341233 ↗
• MalfunctionOct 3, 2025Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE PART WHERE THE INNER SLEEVES SCREW INTO THE OUTER SLEEVE OF ONE (1) RULER 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 23213611 ↗
• MalfunctionAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A PROXIMAL FEMUR FRACTURE FIXATION, ONE (1) RULER FRACTURE DURING USE. THE BREAK OCCURRED AT THE FITTING POINT, BUT THE MEASUREMENT WAS STILL POSSIBLE. THE TEAM IMPROVISED BY GLUING A TAPE MEASURE TO CONTINUE. 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 22892097 ↗
• MalfunctionApr 29, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (1) RULER HAS BROKEN IN NORMAL USE. 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 21927000 ↗
• MalfunctionApr 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE RULER CONNECTION POINT WAS NOTICED TO BE BROKEN, THE TWO PIECES FALL APART. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915667 ↗
• MalfunctionDec 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, A RULER IS 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 21018685 ↗
• MalfunctionDec 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE THREADS OF A (1) RULER WERE BROKEN. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914631 ↗
• MalfunctionNov 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING ORIF TIBIA CASE, THE THREADS OF ONE (X1) RULER BROKE. 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 20684400 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) RULER WAS BROKEN AND WOULD NOT STAY CONNECTED. 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 20306616 ↗
• MalfunctionJul 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE PLASTIC OF THE RULER BROKE FROM CONTINUED WEAR/USAGE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711189 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE TOP OF ONE (1) RULER WAS BROKEN AND CONSEQUENTLY THE TWO PIECES WERE UNABLE TO STAY CONNECTED. 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 19499965 ↗
• MalfunctionMay 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, ONE (1) RULER BROKE AT THE CONNECTION THAT KEEPS BOTH PIECES TOGETHER. 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 19343212 ↗
• MalfunctionApr 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT, THE O-RING ON ONE (1) RULER WAS FRACTURED. AFTER THE FRACTURE OF THE O-RING, THIS ONE FALL IN THE SURGICAL INCISION. THE O-RI G WAS REMOVED WITH A CLAMP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061442 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT ONE (1) RULER WAS FOUND TO BE BROKEN WHILE TAKING LENGTH. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933543 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE RULER END CAP WAS BROKEN. 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 18746380 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT ONE (1) RULER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435768 ↗
• MalfunctionNov 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAIL PROCEDURE, A RULER BROKE WHILE TRYING TO MEASURE LENGTH OF NAIL. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116254 ↗
• MalfunctionOct 10, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE THREADS OF ONE (X1) RULER FROM TRIGEN BASE INSTRUMENT HAD STRIPPED OFF NOT ALLOWING RULER TO BE PLACED TOGETHER CORRECTLY. 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 17907799 ↗
• MalfunctionAug 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A RULER BROKE DURING NORMAL USAGE. 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 17538111 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADS OF A RULER DEPTH GAUGE BROKE OFF WHILE TIGHTENING, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709691 ↗
• MalfunctionOct 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF ONE (1) RULER OR INNER DEPTH GAUGE BROKE OFF AND WONT SCREW BACK ON. THE INSIDE PIECE, AT THE BOTTOM, HAS A THREADED TIP. 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 15628299 ↗
• MalfunctionOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE THREADED PART OF A RULER WAS FOUND BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592132 ↗