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

Model Number	UI30SD100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a dental procedure the tip of their thin swivel direct flow detached in the patient's mouth resulting in them swallowing it.There was no report of patient harm.The patient subsequently saw a physician and the tip was found in the patient's stomach.It is unknown if any medical treatment was administered.
Additional Manufacturer Narrative
The device subject of the reported event was returned to hu-friedy for evaluation.Evaluation results determined that the tip breakage may be attributed to the instrument being dropped prior to the patient procedure or misuse by user facility personnel.The reprocessing of hu-friedy dental hand instruments and accessories states (section 3.2), "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not further use damaged instruments." the device history record (dhr) for the subject lot was reviewed and no abnormalities were noted.No additional issues noted.

• Brand Name: SWIVEL DIRECT FLOW INSERT
• Common Device Name: SCALER
• 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 ; 3232 n rockwell st.; chicago, IL 60618 ; 4403927453
• MDR Report Key: 19332834
• Report Number: 1416605-2024-00005
• Device Sequence Number: 19585623
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: 10889950075620
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 523
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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