MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC ANGULATED BRACKET REMOVING PLIERS, LONG HANDLE

Model Number	678-220L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tooth Fracture (2428)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no report of malfunction of our device associated with the event.The device history record (dhr) was reviewed and no abnormalities were noted.The device subject of the event was requested to be returned to hu-friedy for evaluation.To date, the device has not been returned.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that a patient's tooth broke during a dental procedure which included use of an angulated bracket removing pliers.The patient's tooth was recemented.
Additional Manufacturer Narrative
The device subject of the event was returned for evaluation and no issues were noted.There was no report of malfunction of our device associated with the event.No additional issues have been reported.

• Brand Name: ANGULATED BRACKET REMOVING PLIERS, LONG HANDLE
• Common Device Name: PLIER
• 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: 14379924
• Report Number: 1416605-2022-00003
• Device Sequence Number: 5149539
• Product Code: JEX
• UDI-Device Identifier: 10889950003456
• UDI-Public: 10889950003456
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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 Model Number: 678-220L
• Device Catalogue Number: 678-220L
• Device Lot Number: 0122
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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