MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL HEDSTROEM M-ACCESS 25MM 008; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A16MA02500812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
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 and the lot number was not provided for retained-product testing and/or dhr review.
Event or Problem Description
In this event it is reported that a hedstroem m-access 25mm 008 file broke during use.Reportedly, broken part was removed.Outcome is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Additional information: the product has been scrapped by the customer.The device has been used more than 30 times before the separation.The broken file was caused by the customer's personal operational issue (.) the additional information from sales is as follows: the product packaging has been discarded, and the batch number cannot be found; the patient was not injured; there was no further treatment after the event.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Investigation results 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.Customer stated having used the file more than 30 times before it breaks.Multiple reuses may increase the risks of breakage.Obviously in that case, there was overuse from the customer.Root cause is customer misuse.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 physical investigation of the returned items revealed that no fracture had occurred.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 these/this code(s).

• Brand Name: HEDSTROEM M-ACCESS 25MM 008
• 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: 22991965
• Report Number: 8031010-2025-00152
• Device Sequence Number: 18391741
• Product Code: EKS
• UDI-Device Identifier: J003A16MA025008121
• UDI-Public: J003A16MA025008121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/03/2025

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: A16MA02500812
• Device Lot Number: NOT PROVIDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown