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

Catalog Number	BSTPULR6250SL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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 protaper ultimate slider 31mm x3 file broke during use.The broken part remains in the root canal, doctor incorporated into fill.No injury.
Additional Manufacturer Narrative
Summary: involved product broken during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1781342).For information, the second batch #1784348 provided has no corresponding with the catalog # involved in this complaint (corresponding with bspulr3250sl - protaper ultimate slider 25mm x3).The four unused protaper ultimate slider file 25mm batch #1781342 returned were evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.Correcting udi # from d716pulrsl311 to d716pulrsl251.This is a follow up report for this corrected information.Device received for this event is being corrected from protaper ultimate slider 31mm x3 catalog # bstpulr3310sl to protaper ultimate slider 25mm x6 catalog # bstpulr6250sl.This is a follow up report for this corrected information.

• Brand Name: PROTAPER ULTIMATE SLIDER 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: 18855747
• Report Number: 8031010-2024-00016
• Device Sequence Number: 14279419
• Product Code: EKS
• UDI-Device Identifier: D716PULRSL251
• UDI-Public: D716PULRSL251
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/30/2024

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: BSTPULR6250SL
• Device Lot Number: 1784348 OR 1781342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown