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

Model Number EHB13/14

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 321474659
• Report Number: 1416605-2023-00006
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 10889950009779
• UDI-Public: 10889950009779
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: EHB13/14
• Device Lot Number: 921
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1