MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER FIN.21MM/F1 *NOT CE*; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A041122110112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
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 information regarding the patient outcome has been requested and will be submitted as it becomes available.
Event or Problem Description
In this event it is reported that protaper fin.21mm/f1 *not ce* broke during use.The broken part has not been retrieved.With significant resorption and loosening of the patient's alveolar bone, tooth extraction is required.Received update information before the submission of the initial mdr; the broken file has been removed and destroyed, no return of file.Due to patient's dental issues the doctor recommended tooth extraction.Currently the patient has no toothache symptoms and is fine.

• 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: 20463054
• Report Number: 8031010-2024-00121
• Device Sequence Number: 8701846
• Product Code: EKS
• UDI-Device Identifier: D716PTUHF1211
• UDI-Public: D716PTUHF1211
• 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
• Report Date (Section B): 10/16/2024

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: A041122110112
• Device Lot Number: 1732349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown