MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PATHFILE 21MM 013; FILE, PULP CANAL, ENDODONTIC

Catalog Number	PTH021321
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a pathfile 21mm 013 file broke during use.The broken part has not been retrieved, another appointment has been scheduled to try again to remove the broken part.No injury.
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.
Additional Manufacturer Narrative
Unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented.Case can be re-opened if product is received.No lot number provided for dhr review.

• Brand Name: PATHFILE 21MM 013
• 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: 23053780
• Report Number: 2320721-2025-00092
• Device Sequence Number: 21003884
• Product Code: EKS
• UDI-Device Identifier: D716PTH0213211
• UDI-Public: D716PTH0213211
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/29/2025

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: PTH021321
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown