MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL HEDSTROEM READYSTEEL 25MM 015; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A016D02501504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that hedstrom readysteel 25mm 015 file broke during use.The broken part was not retrieved.No medical or surgical treatment was necessary after the event.No injury occurred.
Additional Manufacturer Narrative
The investigation results for this complaint are root cause cannot be determined.No unused file was returned.The returned product has been evaluated but the cause for the product defect could not be determined.Breakage could not be confirmed - see detailed investigation.Dhr (lot) without fault.

• Brand Name: HEDSTROEM READYSTEEL 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: 22950797
• Report Number: 8031010-2025-00150
• Device Sequence Number: 15566549
• Product Code: EKS
• UDI-Device Identifier: 07630049989412
• UDI-Public: 07630049989412
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/25/2025

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: A016D02501504
• Device Lot Number: 461018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/26/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown