MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY; 100 THIN SWIVEL DIRECT FLOW, 30K

Model Number	UI30SD100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device subject of the reported event was returned to hu-friedy for evaluation.Evaluation determined there were no material heat treatment issues found and the breakage may be attributed to the instrument being driopped or misued.The device history record (dhr) for the subject lot was reviewed and no abnormalities noted.The reprocessing of hu-friedy dental instruments and accessories states, "inspect all instruments after the cleaning and rinsing step for corosion, damaged surfaces, and impurities.Do not further use damaged instruments.".
Event or Problem Description
Dealer/distributor reported insert broke off in patient's mouth during procedure.Tip went to back of patient's throat, unclear if swallowed.Patient was sent to urgent care.

• Brand Name: HU-FRIEDY
• Common Device Name: 100 THIN SWIVEL DIRECT FLOW, 30K
• 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: stephanie wasielewski ; 3232 n. rockwell st.; chicago, IL 60618 ; 8472574500
• MDR Report Key: 21767737
• Report Number: 1416605-2025-00002
• Device Sequence Number: 8427512
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: (01)10889950075620
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 0424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown