M-access® K-REAMER A11MA02102012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI J003A11MA021020121), received between Dec 19, 2023 and Jul 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 21MM 020 BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED, LEFT IN THE CANAL. PATIENT HAS NO ADVERSE REACTIONS. NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22459390 ↗
• MalfunctionFeb 19, 2024Break; Break

  IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 21MM 020 FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED BY AN APICOECTOMY. THE PATIENT RETURNED FOR A FOLLOW UP EXAMINE AFTER THE SURGERY AND REPORTED NO DISCOMFORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18734296 ↗
• MalfunctionJan 4, 2024Break; Break

  IN THIS EVENT IT IS REPORTED THAT K-REAMER M-ACCESS 21MM 020 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. REPORTEDLY, THERE WAS NO INJURY TO PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18444565 ↗
• MalfunctionDec 19, 2023Break; Break

  IN THIS EVENT IT IS REPORTED THAT K-REAMER M-ACCESS 21MM 020 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED FROM PATIENT'S MOUTH. REPORTEDLY, NO INJURY OCCURRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18358605 ↗