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	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a waveone gold reciprocating file primary 25mm file broke during use.The broken part was not retrieved and was incorporated into the fill.No injury.
Additional Manufacturer Narrative
While no injury was reported, 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.Investigation results: nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.Customer not returning.Product not received at investigation site.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• 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: 24713705
• Report Number: 2320721-2026-00027
• Device Sequence Number: 20278050
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME251
• UDI-Public: D716WGPRIME251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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
• Device Lot Number: 0000446374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown