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

Catalog Number	A16MA02501512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr 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 hedstroem m-access 25mm 015 file broke during use.The broken part of the file flew out and injured the oral soft tissue of the patient.The patient immediately experienced severe pain at the injury site.The patient was urgently instructed not to swallow, so they would not swallow the broken part of the file.Upon examination a wound was found on the left oral mucosa that measured approximately 0.2 cm × 0.1 cm, with part of a metal fragment embedded in the wound.The fragment was immediately removed, and gauze was applied for hemostasis.The patient was prescribed oral roxithromycin dispersible tablets as an antibiotic.After 2 follow-up visits, there was no unexpected complications.
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 #1716075).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: HEDSTROEM M-ACCESS 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: 23906709
• Report Number: 8031010-2025-00240
• Device Sequence Number: 13048536
• Product Code: EKS
• UDI-Device Identifier: J003A16MA025015121
• UDI-Public: J003A16MA025015121
• 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): 01/12/2026

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: A16MA02501512
• Device Lot Number: 1716075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/22/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown