MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA ENDO TIP #5 PACK; SCALER, ULTRASONIC

Catalog Number	PUENDO5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.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 a proultra endo tip #5 pack broke during use.The tip was retrieved.No injury occurred.
Additional Manufacturer Narrative
Investigation results: dhr: nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.Return: customer returned 1x puendo5 lot 0000212808 in an autoclave bag.Using microscope visually checked tip.Instrument was broken as indicated in complaint.No manufacturing defects or markings were noted on instrument.Complaint does not indicate what power setting was being used at time of breakage.Root cause of breakage cannot be determined.

• Brand Name: PROULTRA ENDO TIP #5 PACK
• Common Device Name: SCALER, ULTRASONIC
• 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: 17789966
• Report Number: 2320721-2023-00275
• Device Sequence Number: 6252690
• Product Code: ELC
• UDI-Device Identifier: D716PUENDO51
• UDI-Public: D716PUENDO51
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960889
• 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): 10/03/2023

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 Catalogue Number: PUENDO5
• Device Lot Number: 0000212808
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/20/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown