MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA SURGICAL #3 PACK; SCALER, ULTRASONIC

Catalog Number	PUSURG3
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, there has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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 proultra surgical #3 pack tip broke during use.All fragments were 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 3 broken tips in an autoclave pouch.Using microscope visually checked tips.Instrument was broken as indicated in complaint.No manufacturing defects or markings were noted on instruments.Complaint does not indicate what power setting was being used at time of breakage.Several factors may contribute to breakage of tips, such as number of uses, intensity, and pressure.All of these may affect the longevity of the tip.It is recommended that the tip be at treatment site before engaging power.No unopened product was returned for additional testing.Root cause unknown.Failure mode - broken during use root cause - not determined conclusion code - unexpected failure.

• Brand Name: PROULTRA SURGICAL #3 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20219685
• Report Number: 2320721-2024-00059
• Device Sequence Number: 15316177
• Product Code: ELC
• UDI-Device Identifier: D716PUSURG31
• UDI-Public: D716PUSURG31
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960889
• 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): 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: PUSURG3
• Device Lot Number: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2024
• 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