MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL K-FILE M-ACCESS 21MM 008; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A12MA02100812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
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 is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a k-file m-access 21mm 008 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Summary: three k-files m-access 21mm 008 were returned in loose.The three files are bent in the active.One of the file is moreover untwisted in the active part (torque).No material defect was found during analysis of the damaged areas.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1781359.Root causes are not identified.We will track this kind of event and monitor the trend.
Additional Manufacturer Narrative
Additional information received: no injury to patient.The broken parts retrieved from patient's mouth.No additional treatment required after event.Adding additional health effect- clinical code 4582.This is a follow up report to add this additional code.Adding additional health effect- impact code 2991.This is a follow up report to add this additional code.

• Brand Name: K-FILE M-ACCESS 21MM 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17602113
• Report Number: 8031010-2023-00831
• Device Sequence Number: 6307631
• Product Code: EKS
• UDI-Device Identifier: J003A12MA021008121
• UDI-Public: J003A12MA021008121
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/28/2023

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: A12MA02100812
• Device Lot Number: 1781359
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 08/14/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/19/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown