MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL K-FILE M-ACCESS 25MM 015; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A12MA02501512
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Needle Stick/Puncture (2462)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a k-file m-access 25mm 015 file punctured the gloved left thumb of the doctor which caused bleeding.The wound was rinsed with water for 30 seconds and disinfected with alcohol on cotton ball.Further information requested.
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.Investigation results: nothing unusual to report was found during dhr review (batch #1467191).No product was returned, no analysis can be made.For information, dental files we manufacture are active instruments which generally have a sharp tip, and sharp cutting edges.Consequently, these instruments must be handled with care and only by qualified people.Moreover, if pre-bending of the hand use files is not contraindicated, we recommend the use of a dedicated root canal instrument bending device such as flexobend (a0096) to pre-curve the instruments without harming them and without danger for the practitioner.Root causes of the user injury are not formally known but could be the consequence of possible inexperience or lack of knowledge of these products by the user, insufficient training, or misuse.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.
Additional Manufacturer Narrative
Additional information received that the dentist was fine now.This is a follow up report for this additional information.
Additional Manufacturer Narrative
The investigation results for this complaint are: nothing unusual to report was found during dhr review (batch #1467191).No product was returned, no analysis can be made.For information, dental files we manufacture are active instruments which generally have a sharp tip, and sharp cutting edges.Consequently, these instruments must be handled with care and only by qualified people.Moreover, if pre-bending of the hand use files is not contraindicated, we recommend the use of a dedicated root canal instrument bending device such as flexobend (a0096) to pre-curve the instruments without harming them and without danger for the practitioner.Root causes of the user injury are not formally known, but could be the consequence of possible inexperience or lack of knowledge of these products by the user, insufficient training, or misuse.We will track this kind of event and monitor the trend.

• Brand Name: K-FILE M-ACCESS 25MM 015
• 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: 23744202
• Report Number: 8031010-2025-00217
• Device Sequence Number: 10464666
• Product Code: EKS
• UDI-Device Identifier: J003A12MA025015121
• UDI-Public: J003A12MA025015121
• 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,Followup
• Report Date (Section B): 12/18/2025

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: A12MA02501512
• Device Lot Number: 1467191
• 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): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/18/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown