MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HU-FRIEDY; ULTRASONIC SCALER

Model Number	UI30SD1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 1000 triple bend swivel insert subject of the reported event was returned for evaluation.Evaluation results determined that the tip breakage may be attributed to the instrument being dropped prior to the patient procedure or mishandled 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.The return rate for the instrument is low.
Event or Problem Description
User facility reported that insert broke during cleaning.Patient went for x-rays.X-rays were negative.

• Brand Name: HU-FRIEDY
• Common Device Name: ULTRASONIC 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: stephanie wasielewski ; 1666 e. touhy ave.; des plaines, IL 60018 ; 8472574500
• MDR Report Key: 22088174
• Report Number: 1416605-2025-00005
• Device Sequence Number: 12768187
• Product Code: ELC
• UDI-Device Identifier: 10889950075637
• UDI-Public: (01)10889950075637
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: UI30SD1000
• Device Catalogue Number: UI30SD1000
• Device Lot Number: 1023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown