MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWIVEL DIRECT FLOW ULTRASONIC INSERT; SCALER

Model Number	UI30SD100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the tip of their swivel direct flow ultrasonic insert detached in the patient's mouth during a dental procedures.It was reported that the patient was sent to receive a chest x-ray.The chest x-ray confirmed that no piece of the insert was present.The procedure was completed successfully, and no injury was reported.
Additional Manufacturer Narrative
The devices subject of the event were returned to hu-friedy for evaluation, and it was confirmed that the tips of the inserts were broken.Evaluation results determined that the tip breakage may be attributed to the instrument being dropped prior to the patient procedure or misuse by user facility personnel.The reprocessing of hu-friedy dental hand instruments and accessories states (section 3.2), "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not further use damaged instruments".The device history record (dhr) for the subject lots were reviewed and no abnormalities were noted.No additional issues noted.
Event or Problem Description
The user facility reported that the tip of their swivel direct flow ultrasonic insert detached in the patient's mouth during three different dental procedures.It was reported during one procedure that the patient was sent to receive a chest x-ray.The chest x-ray confirmed that no piece of the insert was present.The procedures were completed successfully, and no injuries were reported.

• Brand Name: SWIVEL DIRECT FLOW ULTRASONIC INSERT
• Common Device Name: SCALER
• 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: 19274233
• Report Number: 1416605-2024-00004
• Device Sequence Number: 15190779
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: 10889950075620
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 05/08/2024

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: UI30SD100
• Device Catalogue Number: UI30SD100
• Device Lot Number: 0621, 0622
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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