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)
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 21 cfr 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 a waveone gold glider 015-02/25mm blister 3 us file broke during use.The broken part was left in the tooth and was incorporated into the filling.
Additional Manufacturer Narrative
Customer returned 1x tstw1ww325015 file in autoclave bag that was broken as described by the customer.Checked under microscope and found no manufacturing marks or defects.See attached photo.No unopened product was returned for additional testing.Root cause unknown.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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22063720
• Report Number: 2320721-2025-00073
• Device Sequence Number: 8468442
• Product Code: EKS
• UDI-Device Identifier: D716TSTW1GG3250151
• UDI-Public: D716TSTW1GG3250151
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 06/16/2025

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
• Device Lot Number: 0000421950
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown