MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 13/14 HEIDBRINK ROOT TIP PICK

Model Number	EHB13/14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a dental procedure the user facility was using their 13/14 heidbrink root tip pick to remove the patient's tooth when the tip detached and became stuck in the patient's mouth.The report indicated that the patient will return to have the tip removed.To date, hu-friedy has not received confirmation from the user facility that this has been completed.
Additional Manufacturer Narrative
The device was returned to hu-friedy for evaluation and it was found that both the right and left tips of the device were broken and showed signs of corrosion.The fractured surface on the right tip showed signs of overload failure.The 13/14 heidbrink root tip pick is a delicate instrument designed for removal of root tips or fragments, not to pry the tooth loose.The fractured surface on the left tip had evidence of corrosion likely from poor cleaning practices.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: 13/14 HEIDBRINK ROOT TIP PICK
• Common Device Name: ROOT TIP PICK
• 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: 17556429
• Report Number: 1416605-2023-00006
• Device Sequence Number: 3639705
• Product Code: EMJ
• UDI-Device Identifier: 10889950009779
• UDI-Public: 10889950009779
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

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: EHB13/14
• Device Lot Number: 921
• 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: 07/24/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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