MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER NEXT X2 3FILES 21MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A080322100203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that protaper next x2 3files 21mm file broke during use.It was attempted to remove the broken part by ultrasound, it was separated twice, and 1.5mm remained at the root tip.There is no patient injury occurred.
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  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 #1719841).Root causes are not identified.We will track this kind of event and monitor the trend.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
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 #1719841).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: PROTAPER NEXT X2 3FILES 21MM
• 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: 18101161
• Report Number: 8031010-2023-00865
• Device Sequence Number: 6004098
• Product Code: EKS
• UDI-Device Identifier: D716PTNX2211
• UDI-Public: D716PTNX2211
• 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): 11/10/2023

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: A080322100203
• Device Lot Number: 1719841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/02/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown