MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL K-FILE M-ACCESS 25MM 030; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A12MA02503012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
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
Additional information received; we received the following information regarding this complaint the sales contacted the clinic contact and got that the case did not actually occurred.Please void it.We will at least review the dhr.Summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1771406).Root causes are not identified.We will track this kind of event and monitor the trend.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 broken fragments 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.This is a follow up report for this additional information.Correcting this event from reportable to non reportable.Information was received that this event did not actually happen, please disregard the initial report.As a courtesy we have included the investigation results even though this is not a reportable event.This is a follow up report for this corrected information.

• Brand Name: K-FILE M-ACCESS 25MM 030
• 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: 23745026
• Report Number: 8031010-2025-00223
• Device Sequence Number: 8835510
• Product Code: EKS
• UDI-Device Identifier: J003A12MA025030121
• UDI-Public: J003A12MA025030121
• 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): 12/22/2025

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: A12MA02503012
• Device Lot Number: 1771406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown