MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	WGPRIME25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this case it is reported that a waveone gold reciprocating file primary 25 mm broke during use.Doctor did not provide any other details.Further information requested.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21 cfr part 803.Product discarded and no lot number provided.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: WAVEONE GOLD RECIPROCATING FILE PRIMARY 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21724253
• Report Number: 2320721-2025-00055
• Device Sequence Number: 9437147
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME251
• UDI-Public: D716WGPRIME251
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/28/2025

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: WGPRIME25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown