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	06/20/2024
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 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 glider 015-02/25mm blister 3 us file broke during use.The broken part remains in the canal.Patient referred to specialist.No injury.
Additional Manufacturer Narrative
Failure mode - broken during use.Root cause - no defect proven.Conclusion code - no failure found.Dhr: a quality hold was found during dhr review that could be relative to the issue.A 100% sort was conducted and 297 files were scrapped due to "bad profile and out of specification diameters".See attached dhr.A query indicates no additional complaints have been received for this lot number.Return: customer returned 18x sealed files.Per ansi/aq z1.4-2003 inspector's rule (using single sampling plan 'normal' at inspection level s2 with aql 1.5), a sample lot of 8 were checked.Checked under microscope and found no manufacturing marks or defects.Files were measured using opt comp-007 (calibration date 2/22/2024) and passed all attributes checked (wire size, d3, and d13), see inspection form.Engineering reviewed and advised no further testing required as sealed returned product meets specifications.

• 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: 19578697
• Report Number: 2320721-2024-00041
• Device Sequence Number: 11757290
• Product Code: EKS
• UDI-Device Identifier: D716TSTW1GG3250151
• UDI-Public: D716TSTW1GG3250151
• 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,Followup
• Report Date (Section B): 10/09/2024

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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown