MAUDE Adverse Event Report: DENTSPLY LLC 30K SLI-10S INSERT,PACKED; SCALER, ULTRASONIC

Model Number	79611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a 30k sli-10s insert,packed tip broke during use and was ingested by the patient.The doctor initially told the patient that it would pass but the patient chose to have surgery to have the tip removed.It¿s unclear if the surgery was necessary.
Additional Manufacturer Narrative
There have been previous reports with this or a similar device where this malfunction caused or contributed to a serious injury or required medical/surgical intervention to preclude such.Therefore, this event meets the criteria for a reportable event per 21 cfr 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.
Additional Manufacturer Narrative
Adding udi# - udi# (b)(4).This is a follow up report to add this information.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.No investigation could be done.If there is any additional information or results that become available they will be submitted when they become available.This is to correct and remove the codes that were initially reported - removing codes for: health effect - impact code - 2199.The correct codes for this complaint are: health effect - impact code - 4641.

• Brand Name: 30K SLI-10S INSERT,PACKED
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16532282
• Report Number: 2424472-2023-00358
• Device Sequence Number: 15246361
• Product Code: ELC
• UDI-Device Identifier: D003796111
• UDI-Public: D003796111
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K052334/K970
• 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): 07/20/2023

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: 79611
• Device Catalogue Number: 79611
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown