MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US; FILE, PULP CANAL, ENDODONTIC

Catalog Number	TSTW1GG325015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that waveone gold glider 015-02/25mm blister 3 us file broke during use.The broken part remains in the root canal and incorporated into the filling.No injury.
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.
Additional Manufacturer Narrative
Customer returned 1x tstw1gg325015 in in autoclave bag that had been sterilized.Visually checked under microscope and found no manufacturing marks or defects.File tip was broken as described in the case details.No unopened product was returned therefore no further testing can be performed.Root cause cannot be determined.Nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.

• Brand Name: WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US
• 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: 17481405
• Report Number: 2320721-2023-00268
• Device Sequence Number: 8684913
• Product Code: EKS
• UDI-Device Identifier: D716TSTW1GG3250151
• UDI-Public: D716TSTW1GG3250151
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/21/2023

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: TSTW1GG325015
• Device Lot Number: 0000319394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/08/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown