MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PFILE GT: NT .04 020/21MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	GTR0402021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation and no lot number provided for dhr review.No additional follow up has been received after several attempts have been made.2 (two) unsuccessful requests to retrieve suspect product or investigation result have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per (b)(4).
Event or Problem Description
In this event it is reported that pfile gt: nt.04 020/21mm files, complaint received from doctor the files are breaking.The outcome of this event is unknown as of this md.No further information.Requested additional information.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: PFILE GT: NT .04 020/21MM
• 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: 20543427
• Report Number: 2320721-2024-00065
• Device Sequence Number: 7816494
• Product Code: EKS
• UDI-Device Identifier: D716GTR04020211
• UDI-Public: D716GTR04020211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/12/2024

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: GTR0402021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/21/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown