MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER ULTIMATE SHAPER 25MM X6; FILE, PULP CANAL, ENDODONTIC

Catalog Number	BSTPULR6250SH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); 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.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 protaper ultimate shaper 25mm x6 file broke during use.The broken part could not be retrieved and remains in the root canal.No injury occurred.
Additional Manufacturer Narrative
Summary: the protaper ultimate shaper file 25mm which was returned in loose is actually broken in the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.The batch number is unknown, dhr cannot be reviewed.Root causes are not identified.We will track this kind of event and monitor the trend.Fda coding that was initially reported in the initial report for health effect- clinical code is being corrected from code 4582 to 3165.This is a follow up report to correct this code.

• Brand Name: PROTAPER ULTIMATE SHAPER 25MM X6
• 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: 18118273
• Report Number: 8031010-2023-00866
• Device Sequence Number: 7502968
• Product Code: EKS
• UDI-Device Identifier: D716PULRSH251
• UDI-Public: D716PULRSH251
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/17/2023

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: BSTPULR6250SH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown