MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC GT:SERIES X .06 030/25MM; FILE, PULP CANAL, ENDODONTIC

Model Number	SXR0603025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/15/2023
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 gt:series x.06 030/25mm broke during use.The broken part could not be retrieved and was incorporated into the filling.No injury occurred.
Additional Manufacturer Narrative
Dhr investigation: nothing unusual to report was found during dhr review.Dhr dated 10/03/2022.Query indicates no additional complaints have been received for this lot number.Returned product investigation: returned 2x files.Checked under microscope and found no manufacturing marks or defects.Both files were measured using opt comp-007 (calibration date 2/16/2023) for the following and passed; d0.5, d2, d4.7, d7.5, d11.See attached inspection form.Engineering reviewed files and advised as no further testing required as sealed returned product meets specifications.Root cause: no defect found.Conclusion code: no failure found.

• Brand Name: GT:SERIES X .06 030/25MM
• 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: 17144794
• Report Number: 2320721-2023-00253
• Device Sequence Number: 5421873
• Product Code: EKS
• UDI-Device Identifier: D716SXR06030251
• UDI-Public: D716SXR06030251
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 07/18/2023

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 Model Number: SXR0603025
• Device Catalogue Number: SXR0603025
• Device Lot Number: 0000348183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown