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 Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a protaper fin.21mm/f1 file broke during use.The broken part cannot be retrieved.Doctor recommended that patient go to hospital to remove broken part, patient voluntarily chose to monitor.Reportedly, two days later patient experienced pain in the root tip area and pain while chewing.Appointment made for extraction of tooth.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 information regarding the patient outcome has been requested and will be submitted as it becomes available.
Additional Manufacturer Narrative
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 #1732349).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique (motor setting not communicated), overuse (number of uses not communicated), excessive wear, or material issue (no analysis of the broken fragments possible).Additional information received: the broken file in the root canal was not removed at the customer's location.The doctor suggested going to a more advanced hospital to remove the broken file, but the patient's parents did not accept it.Afterwards, the doctor followed up with the patient ,but no answer.It is currently unknown whether the patient's broken file has been removed and whether the teeth have been extracted.This is a follow up report for this additional information.

• 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: 20064611
• Report Number: 8031010-2024-00106
• Device Sequence Number: 12708948
• Product Code: EKS
• UDI-Device Identifier: D716PTGRF1211
• UDI-Public: D716PTGRF1211
• 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): 09/25/2024

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: A041122110112
• Device Lot Number: 1732349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown