MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL HEDSTROEM M-ACCESS 21MM 020; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A16MA02102012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a hedstroem m-access 21mm 020 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
The investigation results for this complaint are: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1747352).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.
Additional Manufacturer Narrative
We received the following information regarding this complaint 1.The patient was not injured.2.The broken parts was not removed.3.There is no follow-up treatment, and the customer has provided feedback that there is no need for further surgery for the patient.4.The usage frequency is about 20 times, and the specific usage frequency is unclear to the attending doctor.5.This consumable was not retained, will not return.This is a follow up report for this additional information.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 : 3165.Health effect - impact code : 2199.This is a follow up report to correct this code.

• Brand Name: HEDSTROEM M-ACCESS 21MM 020
• 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: 23356734
• Report Number: 8031010-2025-00189
• Device Sequence Number: 15671421
• Product Code: EKS
• UDI-Device Identifier: J003A16MA021020121
• UDI-Public: J003A16MA021020121
• 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,Followup
• Report Date (Section B): 11/10/2025

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: A16MA02102012
• Device Lot Number: 1747352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/15/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/07/2025; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown