MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER SHAP. 19MM/SX*NOT CE*; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A041021910112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/09/2023
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.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 #1752747).Root causes are not identified.We will track this kind of event and monitor the trend.
Event or Problem Description
In this event it is reported that protaper shap.19mm/sx*not ce* file broke during use.The broken part remained in the canal.The patient experienced swelling and pain.The broken part was retrieved 3 days after the event.Approximately a week after the removal the swelling and pain disappeared.

• 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: 18255913
• Report Number: 8031010-2023-00881
• Device Sequence Number: 6644187
• Product Code: EKS
• UDI-Device Identifier: J003A1412200900121
• UDI-Public: J003A1412200900121
• 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): 12/04/2023

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: A041021910112
• Device Lot Number: 1752747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/24/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 12/04/2023
• Date Device Manufactured: 03/01/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown