MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROGLIDER 3FILE STERILE 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A092322500103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/05/2025
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.Investigation results: returned proglider file 25mm is actually broken at the tip of the active part (torque).No material defect was found during analysis of the rupture pattern.For information, second file that broke during use was not returned and cannot be analyzed.No unused file is available for evaluation.No link can be established between breakages issues and information found during dhr review (batch #1895792).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.
Event or Problem Description
In this event it is reported that a proglider 3file sterile 25mm broke during use.The broken part could not be retrieved.The patient was referred to an endo specialist.No injury.

• Brand Name: PROGLIDER 3FILE STERILE 25MM
• 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: 22553442
• Report Number: 8031010-2025-00116
• Device Sequence Number: 9637838
• Product Code: EKS
• UDI-Device Identifier: D716PROGLIDE25DEMO1
• UDI-Public: D716PROGLIDE25DEMO1
• 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
• Report Date (Section B): 07/21/2025

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: A092322500103
• Device Lot Number: 1895792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown