MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWERV3 ULTRASONIC SCALER

Model Number	UM3-30
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a dental procedure the insert detached from the swerv3 ultrasonic scaler and lacerated the patient's tooth.
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation and a lot number was not provided.Without the return of the device, the cause of the reported issue cannot be determined.A follow-up mdr will be submitted should the device be returned for evaluation.

• Brand Name: SWERV3 ULTRASONIC SCALER
• 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: 19073997
• Report Number: 1416605-2024-00002
• Device Sequence Number: 6853878
• Product Code: ELC
• UDI-Device Identifier: 10889950075859
• UDI-Public: 10889950075859
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: UM3-30
• Device Catalogue Number: UM3-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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