MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-PWR-FG-1000 INSERT,PKD; SCALER, ULTRASONIC

Catalog Number	82004
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
Since a broken insert tip could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability 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.
Event or Problem Description
In this event it is reported that a 30k fsi-pwr-fg-1000 insert,pkd broke during use.The insert being used by a student, the tip broke off.Not certain if this happened during use on a patient or not.Since the tip was not located, panoramic x-ray done the following day and chest and abdominal x-ray is also scheduled.
Additional Manufacturer Narrative
Investigation results: the insert involved on the complaint was built on june 19h, 2023.The insert is out of useful life.Dar remem during the dhr review no product deviations were identified no issues identified on the tip and connecting body brazing operation.The insert tip was manually brazed, and no quality defects were identified it was confirmed that the product was manufactured according to specifications.

• Brand Name: 30K FSI-PWR-FG-1000 INSERT,PKD
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20566358
• Report Number: 2424472-2024-00402
• Device Sequence Number: 7817336
• Product Code: ELC
• UDI-Device Identifier: D003820041
• UDI-Public: D003820041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052334
• 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): 01/24/2025

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: 82004
• Device Lot Number: 23170/53
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/24/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown