MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC K FILE: 010 25MM LEXICON STERILIZED; FILE, PULP CANAL, ENDODONTIC

Catalog Number	KFS01025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/20/2024
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 k file: 010 25mm lexicon sterilized file broke during use.Patient was referred to specialist who completed the procedure.The broken part could no be retrieved and was incorporated into the filling.No injury.Case 2 of 3.
Additional Manufacturer Narrative
Unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per 8000-sop-038.

• Brand Name: K FILE: 010 25MM LEXICON STERILIZED
• 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: 19359654
• Report Number: 2320721-2024-00030
• Device Sequence Number: 6342412
• Product Code: EKS
• UDI-Device Identifier: D716KFS010251
• UDI-Public: D716KFS010251
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/16/2024

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: KFS01025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown