M-access® K-FILE A12MA02501512Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI J003A12MA025015121), received between Nov 6, 2023 and Dec 8, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Patient Device Interaction Problem; Sharp Edges; Patient Device Interaction Problem; Sharp Edges

  IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 015 FILE PUNCTURED THE GLOVED LEFT THUMB OF THE DOCTOR WHICH CAUSED BLEEDING. THE WOUND WAS RINSED WITH WATER FOR 30 SECONDS AND DISINFECTED WITH ALCOHOL ON COTTON BALL. FURTHER INFORMATION REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture

  MAUDE report 23744202 ↗
• MalfunctionMay 21, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 015 FILE BROKE DURING USE. REPORTEDLY, THE BROKEN PART WAS RETRIEVED BUT FURTHER INFORMATION REGARDING POTENTIAL PATIENT INJURY IS PENDING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063045 ↗
• MalfunctionMay 7, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25 MM 015 FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED BUT REPORTEDLY ACCIDENTAL TRAUMA OCCURRED. FURTHER INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21977136 ↗
• MalfunctionApr 30, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25 MM 015 FILE BROKE DURING USE. REPORTEDLY, THE BROKEN PART WAS RETRIEVED BUT THERE WAS ACCIDENTAL TRAUMA. REQUESTED FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21934340 ↗
• MalfunctionMar 19, 2025Break; Break

  IN THIS EVENT, IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 015 FILE BROKE DURING USE. THE PATIENT WENT TO ANOTHER HOSPITAL TO HAVE THE BROKEN PART RETRIEVED. THE TREATMENT WAS THEN COMPLETED. REPORTEDLY, NO INJURY. FURTHER INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643255 ↗
• MalfunctionOct 9, 2024Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 015 BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL. NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20406201 ↗
• MalfunctionMay 1, 2024Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 015 BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY OCCURRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19220859 ↗
• MalfunctionNov 6, 2023Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 015 FILE BROKE DURING USE. THE PATIENT WAS SENT TO SPECIALIST FOR REMOVAL OF BROKEN FILE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18073239 ↗