MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL C+FILE READYSTEEL 25MM 006; FILE, PULP CANAL, ENDODONTIC

Catalog Number	6700625
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a c+file readysteel 25mm 006 file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
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.
Additional Manufacturer Narrative
We received the following information regarding this complaint: has any patient been injured? no.Have all the broken parts been retrieved from patient¿s mouth? yes.- has any further medical or surgical treatment been necessary after the event? no.- how many times has the instrument been used before the event happened? once.Investigation results: summary: six c+ files readysteel 25mm 006 were returned (one file in loose + five unused files).File in loose is lightly worn but is not broken.No material defect was found during analysis of the instrument.Nothing unusual to report was found during dhr review (batch #1861934).Unused files were evaluated and were found in compliance with specifications.No fault was found regarding returned products.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code :4580.Health effect - impact code :4648.The correct codes for this complaint are: health effect - clinical code: 4582.Health effect - impact code: 2199.This is a follow up report to correct this code.

• Brand Name: C+FILE READYSTEEL 25MM 006
• 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: 23464445
• Report Number: 8031010-2025-00195
• Device Sequence Number: 21434525
• Product Code: EKS
• UDI-Device Identifier: D71667006251
• UDI-Public: D71667006251
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/08/2025

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: 6700625
• Device Lot Number: 1861934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown