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

Catalog Number	A11MA02503012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a k-reamer m-access 25mm 030 file broke during use.The patient's tooth was extracted.
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.

• Brand Name: K-REAMER M-ACCESS 25MM 030
• Common Device Name: REAMER, 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: 24923401
• Report Number: 8031010-2026-00051
• Device Sequence Number: 13098606
• Product Code: EKP
• UDI-Device Identifier: J003A11MA025030121
• UDI-Public: J003A11MA025030121
• 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): 06/17/2026

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?: Yes
• Device Catalogue Number: A11MA02503012
• Device Lot Number: 1401120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/07/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown