MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROGLIDER ROTARY GLIDE PATH FILES 25 MM LENGTH; FILE, PULP CANAL, ENDODONTIC

Catalog Number	PROGLIDE25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a proglider rotary glide path files 25 mm length 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 has not been returned as of this report.Evaluation results will be submitted as they become available.

• Brand Name: PROGLIDER ROTARY GLIDE PATH FILES 25 MM LENGTH
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19735363
• Report Number: 2320721-2024-00047
• Device Sequence Number: 8009336
• Product Code: EKS
• UDI-Device Identifier: D716PROGLIDE251
• UDI-Public: D716PROGLIDE251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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: PROGLIDE25
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 07/12/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown