MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROGLIDER 3FILE STERILE 21MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A092322100103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that proglider 3file sterile 21mm file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
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 results are not available as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Additional information received that all the broken parts have not been retrieved from the patient's mouth and there was no injury to the patient.Additional information received after the above information: additional information received that the dental treatment given was rct of the affected tooth.Treatment was completed with another set of files.Investigation summary: three proglider files 21mm were returned in loose.The three instruments are broken at the tip of the active part (torque; fatigue + torque; uncertain conditions).No material defect was found during analysis of the rupture patterns.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1772178).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: PROGLIDER 3FILE STERILE 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: 18181076
• Report Number: 8031010-2023-00872
• Device Sequence Number: 7611894
• Product Code: EKS
• UDI-Device Identifier: D716PROGLIDE211
• UDI-Public: D716PROGLIDE211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/04/2024

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: A092322100103
• Device Lot Number: 1772178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown