MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL K-FILE M-ACCESS 21MM 008; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A12MA02100812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	09/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that a k-file m-access 21mm 008 file broke during use.The broken part could not be retrieved and the tooth was removed.The patient is fine now.The device was discarded.
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.Investigation summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.The provided batch number #20250423 turns out have no corresponding in our system.True batch number is unknown, dhr cannot be reviewed.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.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.

• Brand Name: K-FILE M-ACCESS 21MM 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: 23708432
• Report Number: 8031010-2025-00211
• Device Sequence Number: 13422161
• Product Code: EKS
• UDI-Device Identifier: J003A12MA021008121
• UDI-Public: J003A12MA021008121
• 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): 12/03/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: A12MA02100812
• Device Lot Number: 20250423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/12/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown