MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 303 APEXO ELEVATOR

Model Number	E303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number or model of the device subject of the event was not provided.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
Hu-friedy was notified of a complaint where the tip of a dental elevator detached in a patient's mouth during a dental procedure on (b)(6) 2020.The tip of the dental elevator was removed from the patient's jaw during a subsequent procedure.

• Brand Name: 303 APEXO ELEVATOR
• Common Device Name: ELEVATOR
• 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: 14416714
• Report Number: 1416605-2022-00005
• Device Sequence Number: 5474450
• Product Code: EMJ
• UDI-Device Identifier: 10889950009120
• UDI-Public: 10889950009120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2022

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: E303
• Device Catalogue Number: E303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 03/22/2022; 03/22/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/01/2023; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown