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

Model Number	UI30SSXT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a dental cleaning procedure the tip of ultrasonic insert detached from the handpiece and it split the patient lip.
Additional Manufacturer Narrative
The device subject of the reported event wasn't returned to hu-friedy for evaluation.The device history record for the subject lot was reviewed and no abnormalities were noted.
Additional Manufacturer Narrative
The device subject of the reported event was returned to hu-friedy for evaluation.Evaluation found that the breakage may be due to dropped, or misused insert.The reprocessing of hu-friedy dental hand instruments and accessories states "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not use damaged instruments.".

• Brand Name: HU-FRIEDY
• Common Device Name: SWIVEL XT, 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
• MDR Report Key: 20407860
• Report Number: 1416605-2024-00010
• Device Sequence Number: 6546431
• Product Code: ELC
• UDI-Device Identifier: 10889950075798
• UDI-Public: (01)10889950075798
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: Other
• Device Model Number: UI30SSXT
• Device Catalogue Number: UI30SSXT
• Device Lot Number: 0823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown