MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROFILE VORTEX BLUE 06/15 30MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	VTB061530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/21/2025
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 21 cfr 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 a profile vortex blue 06/15 30 mm file broke during use.The broken part was not retrieved.No injury.
Additional Manufacturer Narrative
Customer returned 1 loose file in an autoclave bag, broken at 14mm from the handle.The file was checked under microscope and found no manufacturing marks or defects.See attached photo.No lot number provided.No unopened product was returned therefore no further testing can be performed.Engineering reviewed, looking at the file under magnification, nothing points to a void or inclusion.The cross section aligns with the expectations at 3 mm.The break does not appear to be related to a manufacturing defect.

• Brand Name: PROFILE VORTEX BLUE 06/15 30MM
• 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: 21207871
• Report Number: 2320721-2025-00042
• Device Sequence Number: 20872238
• Product Code: EKS
• UDI-Device Identifier: D716VTB0615301
• UDI-Public: D716VTB0615301
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 02/04/2025

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: VTB061530
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/21/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown