MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC TRUNATOMY ASSORTED 25MM STERILE 6 PACK; FILE, PULP CANAL, ENDODONTIC

Catalog Number	TRNAST625
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a trunatomy assorted 25mm sterile 6 pack file broke during use.The broken part was not retrieved and was incorporated into the filling.No injury occurred.
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 was done.A quality hold was found during dhr review but does not relate to the issue.A query indicates no additional complaints have been received for this lot number.- customer not returning.  product not received at investigation site.

• Brand Name: TRUNATOMY ASSORTED 25MM STERILE 6 PACK
• 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: 17396838
• Report Number: 2320721-2023-00265
• Device Sequence Number: 15346382
• Product Code: EKS
• UDI-Device Identifier: D716TRNAST6251
• UDI-Public: D716TRNAST6251
• Combination Product (Y/N): N
• 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): 07/26/2023

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: TRNAST625
• Device Lot Number: 0000363832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/26/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown