MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWIVEL DIRECT FLOW ULTRASONIC INSERT; SCALER, ULTRASONIC

Model Number	UI30SD100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the tip of their swivel direct flow ultrasonic insert detached in the patient's mouth during a dental procedure and the patient swallowed the tip.It was reported that the patient was sent to receive x-rays.
Additional Manufacturer Narrative
Hu-friedy has requested additional information from the user facility regarding the patient status.However; to date a response has not been received.The device subject of the event was returned to hu-friedy for evaluation and the device was confirmed to have broken at the tip.The evaluation found that the area where the break occurred showed evidence of corrosion.The damage may have been caused by facility personnel mishandling, dropping, or insufficiently cleaning the insert.The hu-friedy instrument reprocessing guide states "3.2 inspection inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not further use damaged instruments" the device was manufactured in 2017 making it approximately 6 years old.A follow-up mdr will be submitted should additional information becomes available.

• Brand Name: SWIVEL DIRECT FLOW ULTRASONIC INSERT
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14379965
• Report Number: 1416605-2022-00004
• Device Sequence Number: 14700031
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: 10889950075620
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UI30SD100
• Device Catalogue Number: UI30SD100
• Device Lot Number: 1017
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown