MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC K FILE: 015 25MM LEXICON STERILIZED; FILE, PULP CANAL, ENDODONTIC

Catalog Number	KFS01525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/02/2024
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: 015 25mm lexicon sterilized file broke during use.The files could not be retrieved and the patient was referred to a specialist.No injury.
Additional Manufacturer Narrative
Investigation results: internal investigation results received: instruments produced according to specifications.Dhr checked performed.No fault found.No changes in production.Root cause cannot be identified.Complaint is registered and we will monitor the trend.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: K FILE: 015 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: 19665689
• Report Number: 2320721-2024-00046
• Device Sequence Number: 12418140
• Product Code: EKS
• UDI-Device Identifier: D716KFS015251
• UDI-Public: D716KFS015251
• 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): 12/09/2024

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: KFS01525
• Device Lot Number: 442675
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown