MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PRO-RINSE 30G MAXP301T; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Catalog Number	MAXP301T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 a prorinse irrigation probe broke during use.No injury occurred.
Additional Manufacturer Narrative
Investigation completed: 41 unused prorinse irrigating probes 30g were returned.These probes were observed, none of them is visually damaged (not broken and not bent beyond 10°) or clogged.The involved probes used by the customer and which were damaged during use are not available and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1868662).Root causes are not identified.We will track this kind of event and monitor the trend.For information, no bending test is applicable for this type of product.Prorinse probes are devices which are intended to be passively inserted inside the canal to treat.Only a ligth pre-curvation of the tube from the customer is allowed but it does not exceed 25°.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: PRO-RINSE 30G MAXP301T
• Common Device Name: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• 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: 20263787
• Report Number: 2320721-2024-00060
• Device Sequence Number: 8261726
• Product Code: EIC
• UDI-Device Identifier: D716MAXP301T1
• UDI-Public: D716MAXP301T1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/24/2024

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: MAXP301T
• Device Lot Number: 1868662
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown