MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL NITIFLEX FILE 25MM 015; FILE, PULP CANAL, ENDODONTIC

Model Number	TEKF1525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.The device is available for evaluation, though has not been returned 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 nitiflex file 25mm 015 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Additional information received as to the outcome of this event.The broken part remained in the root canal after the event and the patient was referred to endodontic specialist to remove the broken part.After further treatment the broken part was removed from the patient's root canal.All broken parts have been retrieved.Additional information for the lot # has also been received.The lot # is 1801333.
Additional Manufacturer Narrative
Summary: three nitiflex files 25mm 015 were returned in loose.One of the files is not broken but bent at the base of the active part (fatigue).No material defect was found during analysis of the damaged area.The two other files were used but are not broken, not damaged.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1801333).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: NITIFLEX FILE 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17225976
• Report Number: 8031010-2023-00805
• Device Sequence Number: 20627318
• Product Code: EKS
• UDI-Device Identifier: D716TEKF15251
• UDI-Public: D716TEKF15251
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 09/05/2023

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 Model Number: TEKF1525
• Device Catalogue Number: A012N02501500
• Device Lot Number: 1801333
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 06/29/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/10/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown