MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL HEDSTROEM M-ACCESS 21MM 015; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A16MA02101512
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.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.
Event or Problem Description
In this event it is reported that hedstroem m-access 21mm 015 that was used in treatment of a patient, punctured the patient in the mouth which led to bleeding gums.Treatment was completed and patient had no discomfort.
Additional Manufacturer Narrative
Additional information received that there was a small amount of bleeding at the time and it was resolved soon.No further treatment is required.Investigation summary: involved product that didn't give satisfaction was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1852692).Root causes are not identified.We will track this kind of event and monitor the trend.Please note for information that hedstroem files m-access 21mm 015 have a pointed tip.In consequence, these instruments must be handled with care before canal preparation to avoid any patient injury.

• Brand Name: HEDSTROEM M-ACCESS 21MM 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: 19220771
• Report Number: 8031010-2024-00050
• Device Sequence Number: 12810586
• Product Code: EKS
• UDI-Device Identifier: J003A16MA021015121
• UDI-Public: J003A16MA021015121
• 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): 05/14/2024

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?: No
• Device Catalogue Number: A16MA02101512
• Device Lot Number: 1852692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/28/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown