MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL C+FILE READYSTEEL 21MM 010; FILE, PULP CANAL, ENDODONTIC

Catalog Number	6701021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a c+file readysteel 21 mm 010 file broke during use.The tip of the file broke and is causing pain to the patient.The broken part was washed by root canal treatment equipment, and a tooth x-ray was taken, which showed that it was not in the root canal.
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 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative
Involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.The 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.

• Brand Name: C+FILE READYSTEEL 21MM 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: 22193089
• Report Number: 8031010-2025-00098
• Device Sequence Number: 8562131
• Product Code: EKS
• UDI-Device Identifier: D71667010211
• UDI-Public: D71667010211
• 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
• Report Date (Section B): 07/10/2025

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: 6701021
• Device Lot Number: NOT PROVIDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown