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)
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.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.
Event or Problem Description
In this event it is reported that a c+file readysteel 25 mm 006 file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
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? [after using several files from the package, the doctor decided they no longer have strengths, and they to break more quickly compared to previously purchased tools of the same type] this is a follow up report for this additional information.Summary: involved c+files readysteel 25mm 006 that broke or that bent during use were not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1930998).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique, 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.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: 24496958
• Report Number: 8031010-2026-00024
• Device Sequence Number: 20072444
• Product Code: EKS
• UDI-Device Identifier: D71667006251
• UDI-Public: D71667006251
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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): 03/25/2026

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: 1930998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown