M-access K-FILERecalls & reported problems across all models
MAILLEFER INSTRUMENTS HOLDING Sàrl · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 18 models of M-access K-FILE by MAILLEFER INSTRUMENTS HOLDING Sàrl in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Aug 23, 2023 and Jun 9, 2026 — classified as 4 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Break” (49 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported M-access K-FILE problems
Device problems
- Break49
- Patient Device Interaction Problem1
- Sharp Edges1
Patient problems
- Device Embedded In Tissue or Plaque19
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information16
- Tooth Loss3
- Hemorrhage/Blood Loss/Bleeding2
- Needle Stick/Puncture2
- Pain2
- Unspecified Infection1
M-access K-FILE models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M-access® K-FILE A12MA02501012FILE, PULP CANAL, ENDODONTIC10 reports
- M-access® K-FILE A12MA02501512FILE, PULP CANAL, ENDODONTIC8 reports
- M-access® K-FILE A12MA02101012FILE, PULP CANAL, ENDODONTIC5 reports
- M-access® K-FILE A12MA02101512FILE, PULP CANAL, ENDODONTIC4 reports
- M-access® K-FILE A12MA02502512FILE, PULP CANAL, ENDODONTIC4 reports
- M-access® K-FILE A12MA02100612FILE, PULP CANAL, ENDODONTIC2 reports
- M-access® K-FILE A12MA02100812FILE, PULP CANAL, ENDODONTIC2 reports
- M-access® K-FILE A12MA02102012FILE, PULP CANAL, ENDODONTIC2 reports
- M-access® K-FILE A12MA02102512FILE, PULP CANAL, ENDODONTIC2 reports
- M-access® K-FILE A12MA02500612FILE, PULP CANAL, ENDODONTIC2 reports
- M-access® K-FILE A12MA02502012FILE, PULP CANAL, ENDODONTIC2 reports
- M-access® K-FILE A12MA02190012FILE, PULP CANAL, ENDODONTIC1 report
- M-access® K-FILE A12MA02500812FILE, PULP CANAL, ENDODONTIC1 report
- M-access® K-FILE A12MA02503012FILE, PULP CANAL, ENDODONTIC1 report
- M-access® K-FILE A12MA02503512FILE, PULP CANAL, ENDODONTIC1 report
- M-access® K-FILE A12MA02504012FILE, PULP CANAL, ENDODONTIC1 report
- M-access® K-FILE A12MA03100812FILE, PULP CANAL, ENDODONTIC1 report
- M-access® K-FILE A12MA03111012FILE, PULP CANAL, ENDODONTIC1 report
Recent M-access K-FILE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 025 FILE BROKE DURING USE. IT WAS ATTEMPTED TO RETRIEVE THE BROKEN PART. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25448259 ↗MalfunctionJun 4, 2026Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 020 FILE BROKE DURING USE. THE ROOT CANAL WAS EXPANDED AND THE BROKEN PART WAS RETRIEVED. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25389901 ↗MalfunctionMar 30, 2026Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 010 FILE BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712231 ↗MalfunctionDec 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 15-40 FILE BROKE DURING USE. THE BROKE PART STILL REMAINS IN THE ROOT CANAL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23854124 ↗MalfunctionDec 16, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 010 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL. THE PATIENT WILL BE OBSERVED. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23818687 ↗MalfunctionDec 8, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 030 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE SUCCESSFULLY REMOVED. TO RELIEVE THE PAIN THE PATIENT WAS IN THE TOOTH WAS EXTRACTED.
Patient problems: Tooth Loss
MAUDE report 23745026 ↗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 ↗MalfunctionDec 8, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 020 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. NO INJURY. FURTHER INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744039 ↗MalfunctionDec 8, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 FILE BENT AND DEFORMED DURING USE. THIS RESULTED IN INCOMPLETE TREATMENT AND THE PATIENT CAN ONLY HAVE THE TOOTH EXTRACTED. FURTHER INFORMATION REQUESTED.
Patient problems: Tooth Loss
MAUDE report 23743745 ↗MalfunctionDec 8, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS LEFT IN THE CANAL. FURTHER INFORMATION RECEIVED THAT THE BROKEN PART HAS BEEN REMOVED BY ANOTHER HOSPITAL. THE PATIENT IS FINE NOW. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742953 ↗MalfunctionDec 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 006 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO FURTHER TREATMENT REQUIRED. NO INJURY TO PATIENT. THE BROKEN DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23716058 ↗MalfunctionDec 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 010 FILE BROKE DURING USE. NO INJURY. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 23715034 ↗InjuryDec 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 008 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND THE TOOTH WAS REMOVED. THE PATIENT IS FINE NOW. THE DEVICE WAS DISCARDED.
Patient problems: Tooth Loss
MAUDE report 23708432 ↗InjuryDec 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 025 FILE BROKE DURING USE. THE BROKEN PART TOUCHED THE PATIENT'S GUM. IODINE AND DISINFECT APPLIED BY PRESSURE WITH A COTTON BALL TO STOP BLEEDING. THE DEVICE WAS NOT RETAINED AND THE PATIENT IS FINE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708326 ↗MalfunctionNov 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 020 FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED BY MICROSCOPE AND ULTRASOUND. PATIENT OUTCOME IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23541885 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page