MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROFILE VORTEX BLUE 04/25 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	VTB042525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2024
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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are: customer not returning.  product not received at investigation site.Nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.
Event or Problem Description
In this event it is reported that profile vortex blue 04/25 25mm file broke during use.The file broke during a procedure mid root on tooth #3.The broken part was not retrieved and was incorporated into the filling.No injury.The file was discarded.

• Brand Name: PROFILE VORTEX BLUE 04/25 25MM
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18457466
• Report Number: 2320721-2024-00001
• Device Sequence Number: 12532501
• Product Code: EKS
• UDI-Device Identifier: D716VTB0425251
• UDI-Public: D716VTB0425251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/05/2024

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: VTB042525
• Device Lot Number: 0000368163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown