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

Model Number	PULRSH25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
In this event it is reported that protaper ultimate rotary file shaper 25mm broke during use.The broken part could not be retrieved and was incorporated into the filling.No injury.
Additional Manufacturer Narrative
Investigation results: dhr.Nothing unusual to report was found during dhr review.Dhr dated 5/4/2022.Query indicates no additional complaints have been received for this lot number.Return customer returned 16x 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 2/16/2023) for d3, d13, and wire diameter; files passed.See attached inspections form.Engineering reviewed and advised as no further testing required as sealed returned product meets specifications.

• Brand Name: PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 5100 e skelly dr ste 300; tulsa OK 74135
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 5100 e skelly dr ste 300; tulsa OK 74135
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17229298
• Report Number: 2320721-2023-00261
• Device Sequence Number: 20627439
• Product Code: EKS
• UDI-Device Identifier: D716PULRSH251
• UDI-Public: D716PULRSH251
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 08/07/2023

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 Model Number: PULRSH25
• Device Catalogue Number: PULRSH25
• Device Lot Number: 309284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown