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	02/20/2026
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 21cfr part 803.The device is available for evaluation, though results are not available 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.The broken part was not retrieved and was incorporated into the filling.No injury.
Additional Manufacturer Narrative
The investigation results for this complaint are: returned 2 sealed files and 1 broken file lot 0000450499.Checked under microscope and found no manufacturing defects or marks.The loose file was broken at 9mm from the handle.The 2 sealed files were measured using opt (b)(4) (calibration date 2/25/20264) and passed all attributes checked (wire size, d3, and d9), see attached inspection form.Returned sealed product meets specification.Engineering reviewed the broken file and found no irregularities that would have caused the breakage therefore no further testing is recommended at this time.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 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: 24485194
• Report Number: 2320721-2026-00017
• Device Sequence Number: 21486986
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME251
• UDI-Public: D716WGPRIME251
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/03/2026

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: 0000450499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown