MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 5/6 BARNHART CURETTE, USC/SUTER

Model Number	SBH5/6USC9E2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a dental procedure a piece of one of the tips to their 5/6 barnhart curette, usc/suter detached in the patient's mouth.The part was surgically removed.
Additional Manufacturer Narrative
The device was returned to hu-friedy for evaluation without the detached piece and the fractured surface on the broken tip showed signs of overload failure.Additionally, the returned device had residue, corrosion, and scratches.The device has two tips and the other unbroken tip showed signs of dullness.This dullness would cause additional force to be required to use the device and could result in the reported failure.As the detached piece was not returned, we are unable to confirm if it showed signs of dullness.The device history record for the lot number subject of the reported event was reviewed and no abnormalities were noted.A 12 month complaint review indicates this to be an isolated event.The hu-friedy instrument reprocessing guide states "3.2 inspection inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not further use damaged instruments." no additional issues have been reported.

• Brand Name: 5/6 BARNHART CURETTE, USC/SUTER
• Common Device Name: CURETTE
• 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: 17398933
• Report Number: 1416605-2023-00005
• Device Sequence Number: 5955843
• Product Code: EMS
• UDI-Device Identifier: 10889950102616
• UDI-Public: 10889950102616
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 07/26/2023

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: SBH5/6USC9E2
• Device Lot Number: 821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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