MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL K-FILE M-ACCESS 31MM 008; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A12MA03100812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a k-file m-access 31mm 008 file broke during use causing the patient to have a toothache.After taking an x-ray, it was found that about 2mm of file tip was left in the canal, resulting in periapical infection.The dentist used ultrasonic to retrieve broken part.
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Additional Manufacturer Narrative
The batch number is known, certificate of conformity is available.We found during dhr review the qh #77514, issued during twisting / sharpening operation because the blank files were too short in length.Production was finally accepted according f804.112.No incidence on the final production.For information, this is the first complaint received involving this batch number for this issue.
Additional Manufacturer Narrative
Additional information received: we received the following information: i called the reporter on september 3, 2025, september 9, 2025, and september 12, 2025, but no one answered.The reporter just called me back and confirmed upon inquiry that the case did not actually occur.Please void it.We will investigate anyway as the complaint has indeed been created.This is a follow up report for this additional information that has been received.Correcting this mdr to non- reportable.This follow up report is to correct this event to a non-reportable.This is being changed due to additional information that has been received.Please disregard the initial report.

• Brand Name: K-FILE M-ACCESS 31MM 008
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22966038
• Report Number: 8031010-2025-00151
• Device Sequence Number: 9062559
• Product Code: EKS
• UDI-Device Identifier: J003A12MA031008121
• UDI-Public: J003A12MA031008121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: A12MA03100812
• Device Lot Number: 1899334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/05/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown