MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL K-FILE M-ACCESS 25MM 010; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A12MA02501012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr 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 investigation results for this complaint involved product that didn't give satisfaction during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.The provided batch #049484 has no corresponding in our system.Right batch number is unknown, dhr cannot be reviewed.Root causes are not identified.Potential root causes may be incorrect technique (hand used file - technique no more verifiable to date), overuse (number of uses not communicated), excessive wear, patient condition and behavior during treatment or material issue (no analysis of the files possible).In addition, there are further circumstances on the conditions in dentistry (used disinfectants, training/knowledge status), or any other environmental conditions, which are unknown to us and may also have an impact on the reported failure mode.

• Brand Name: K-FILE M-ACCESS 25MM 010
• 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: 23743745
• Report Number: 8031010-2025-00220
• Device Sequence Number: 18667024
• Product Code: EKS
• UDI-Device Identifier: J003A12MA025010121
• UDI-Public: J003A12MA025010121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/21/2026

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: A12MA02501012
• Device Lot Number: PR:049484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown