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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of this malfunction, surgical intervention was conducted 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.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 reciprocating file primary 25mm file broke during use.Patient was referred to endo specialist who removed the file and completed the procedure.File discarded.No injury.
Additional Manufacturer Narrative
Additional information received that no patient injured, and all the broken parts retrieved from the patient mouth.Since this is the case the (b)(4) applies (broken parts retrieved - no patient's injury) applies to this event and is not reportable.Please disregard the initial report.Correcting this event from reportable to non-reportable after receiving additional information.Since this is the case the (b)(4) applies (broken parts retrieved - no patient's injury) applies to this event and is not reportable.Please disregard the initial report.

• 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: 21960264
• Report Number: 2320721-2025-00069
• Device Sequence Number: 9188413
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME251
• UDI-Public: D716WGPRIME251
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/05/2025

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
• Device Lot Number: 0000408946
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown