MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROTAPER GOLD ROTARY S1 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	PTGRS125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/20/2024
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 protaper gold rotary s1 25mm file broke during use.The broken part was not retrieved.Patient is being watched for any adverse effects, currently they re asymptomatic.No injury.
Additional Manufacturer Narrative
Investigation results: dhr: nothing unusual to report was found during dhr reviews.A query indicates no additional complaints have been received for these lot numbers.Returned: returned 25 sealed packs (150 files) of lot 0000356632 but no broken file.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 (b)(6) 2024) and passed all attributes checked, d2, d6, d13, and wire size and also lab testing was completed on 3 files and passed, see attached inspection/testing forms.Returned sealed product meets specifications.

• Brand Name: PROTAPER GOLD ROTARY S1 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18948901
• Report Number: 2320721-2024-00019
• Device Sequence Number: 17913523
• Product Code: EKS
• UDI-Device Identifier: D716PTGRS1251
• UDI-Public: D716PTGRS1251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/08/2024

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: PTGRS125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/20/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown