MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY; 10 SWIVEL DIRECT FLOW 30K

Model Number	UI30SD10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device received and it appears that the housing came off due to the insert sticking in the handpiece.The damage to the steel component that holds the external o-rings may have contributed to the insert sticking in the handpiece, however, no conclusive finding is available.
Event or Problem Description
Customer called in stating they were using an ultrasonic insert in their dentsply caviton steri mate 360 - when attempting to remove insert from handpiece, the insert was stuck.Attempted several times to remove, however, resulted in doctor and hygienist cutting themselves during attempt.

• Brand Name: HU-FRIEDY
• Common Device Name: 10 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: 23588068
• Report Number: 1416605-2025-00008
• Device Sequence Number: 15847340
• Product Code: ELC
• UDI-Device Identifier: 10889950075613
• UDI-Public: (01)10889950075613
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: UI30SD10
• Device Catalogue Number: UI30SD10
• Device Lot Number: 1024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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