MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL HEDSTROEM M-ACCESS 25MM 010; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A16MA02501012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that a hedstroem m-access 25mm 010 broke during use.The tip of the file was found an x-ray examination that was done at a follow-up visit.Following the breakage, there was an abscess in the gingival area on the buccal side of the left upper posterior tooth, which affected the left cheek and caused significant pain.Incision and drainage of buccal abscess were done due to the high difficulty of removing the broken file.Followed by dental treatment, observation of the broken needle, conservative treatment, and outpatient follow-up.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.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.
Additional Manufacturer Narrative
Additional information received that the broken part has been retrieved.The k file has been discarded.This is a follow up report for this additional information.Investigation results: summary: 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 #1874449).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 (multiple reuses may increase risks of breakages), excessive wear, or material issue (no analysis of the broken fragments possible).

• Brand Name: HEDSTROEM M-ACCESS 25MM 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: 20773098
• Report Number: 8031010-2024-00146
• Device Sequence Number: 18164825
• Product Code: EKS
• UDI-Device Identifier: J003A16MA025010121
• UDI-Public: J003A16MA025010121
• 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): 12/28/2024

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?: Yes
• Device Catalogue Number: A16MA02501012
• Device Lot Number: 1874449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown