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	05/13/2025
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 21cfr part 803.Customer not returning.Product not received at investigation site.
Event or Problem Description
In this event it is reported that a waveone gold glider 015-02/25mm blister 3 us broke during use.Doctor was working on a calcified canal on tooth #5, approximately 3mm of the tip broke near the apex.Doctor filled behind.File was discarded.No injury.
Additional Manufacturer Narrative
No product will be returned for investigation.Product was discarded and no lot number available for investigation of dhr.

• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22025229
• Report Number: 2320721-2025-00072
• Device Sequence Number: 7136200
• Product Code: EKS
• UDI-Device Identifier: D716TSTW1GG3250151
• UDI-Public: D716TSTW1GG3250151
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 06/18/2025

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: TSTW1GG325015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown