MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC P10 PIEZO SCALING TIP; SCALER

Model Number	USP10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was returned for evaluation and confirmed the device was broken at the end of the water slot.Additionally, it was found that the tip angle of the device was bent inwards which is indicative of the device being dropped or mishandled.The current stock inventory of the usp10 was reviewed and found to be within specifications.Through follow-up with user facility personnel, hufriedy learned that the customer was using the tip on high power and with excess pressure.The usp10 is a medium power tip.Hufriedy counseled user facility personnel on the proper use and operation of the usp10, including how to set and use the power at medium.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a dental procedure the tip of their p10 piezo tip s-series (usp10) detached in the patient's mouth and was swallowed.It was reported that the patient was sent to receive a chest x-ray which was negative confirming the tip had been swallowed.

• Brand Name: P10 PIEZO SCALING TIP
• 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: 16864878
• Report Number: 1416605-2023-00002
• Device Sequence Number: 12117665
• Product Code: ELC
• UDI-Device Identifier: 10889950076030
• UDI-Public: 10889950076030
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/03/2023

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: USP10
• Device Catalogue Number: USP10
• Device Lot Number: 822
• 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: 04/06/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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