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	Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
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.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 #1734455).Root causes are not identified.We will track this kind of event and monitor the trend.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
Event or Problem Description
In this event it is reported that k-file m-access 25mm 010 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

• 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: 19762144
• Report Number: 8031010-2024-00083
• Device Sequence Number: 15647948
• Product Code: EKS
• UDI-Device Identifier: J003A12MA025010121
• UDI-Public: J003A12MA025010121
• 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
• Report Date (Section B): 07/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A12MA02501012
• Device Lot Number: 1773131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown