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	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a waveone gold glider 015-02/25mm blister 3 us broke during use.The broken part was not retrieved.The canal was treated and the patient will return for further treatment.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.Investigation results: nothing unusual to report was found during dhr review.Dhr dated 2/07/2024.Query indicates no additional complaints have been received for this lot number.Customer not returning.Product not received at investigation site.No other complaints have been recieved 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: 19613379
• Report Number: 2320721-2024-00043
• Device Sequence Number: 6228603
• Product Code: EKS
• UDI-Device Identifier: D716TSTW1GG3250151
• UDI-Public: D716TSTW1GG3250151
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 06/26/2024

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: 06/25/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown