MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC #7/8 GRACEY CURETTE, #7 HANDLE, GREEN

Catalog Number	SG7/877
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was returned for evaluation and the breakage was confirmed at the blade bend angle.The appearance of the surface where the break occurred as well as the location of the break at the blade bend angle are indicative of the device being subjected to impact damage.The device may have been dropped or mishandled by user facility personnel.The damage to the device caused the tip to detach resulting in the reported event.The device history record of the lot subject of the event was reviewed and no abnormalities were found.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that the tip of their gracey curette detached in the patient's mouth during a dental procedure and the patient swallowed the tip.The tip of the gracey curette was removed from the patient during a subsequent endoscopic procedure.

• Brand Name: #7/8 GRACEY CURETTE, #7 HANDLE, GREEN
• 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 ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14733340
• Report Number: 1416605-2022-00007
• Device Sequence Number: 2351394
• Product Code: EMS
• UDI-Device Identifier: 10889950095598
• UDI-Public: 10889950095598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/17/2022

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 Catalogue Number: SG7/877
• Device Lot Number: 0821
• 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: 06/02/2022
• Initial Report FDA Received Date: 06/17/2022
• 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