MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 1000 TRIPLE BEND STREAMLINE ULTRASONIC INSERT; SCALER, ULTRASONIC

Model Number	UI100030K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the tip of their 1000 triple bend streamline ultrasonic insert detached in the patient's mouth during a dental procedure and the patient swallowed the tip.The patient was sent to the emergency room to receive an x-ray.
Additional Manufacturer Narrative
Hu-friedy has requested additional information from the user facility regarding the patient status; however, to date a response has not been received.The device subject of the event was returned for evaluation and it was confirmed that the tip of the insert was broken.The damage observed is indicative of the insert being misused or mishandled by user facility personnel.There have been no similar complaints associated with this lot.No additional issues have been reported.

• Brand Name: 1000 TRIPLE BEND STREAMLINE ULTRASONIC INSERT
• Common Device Name: SCALER, ULTRASONIC
• 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: 14462091
• Report Number: 1416605-2022-00006
• Device Sequence Number: 11888150
• Product Code: ELC
• UDI-Device Identifier: 10889950075248
• UDI-Public: 10889950075248
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

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: UI100030K
• Device Catalogue Number: UI100030K
• Device Lot Number: 1221
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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