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)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received 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.Investigation results: no lot number provided and product was discarded nothing to return.Failure mode: broken during use.Root cause: product not received at investigation site.Conclusion code: indeterminable.
Event or Problem Description
In this event it is reported that proultra endo tip #5 pack broke during use.No injury occurred.

• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20146980
• Report Number: 2320721-2024-00055
• Device Sequence Number: 8259559
• 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
• Report Date (Section B): 09/05/2024

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: PUENDO5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/05/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown