MAUDE Adverse Event Report: SS WHITE BURS LLC SS WHITE CARBIDE BUR; DENTAL BUR

Model Number	HP-PBUR-SC702LA
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 that during the dental procedure the tip of bur broke off in a patient's mouth.No patient injury was reported and no event date was reported.Ss white burs received medwatch report mw5171690 on july 2, 2025, from the fda.
Additional Manufacturer Narrative
The reported device was not returned for investigation.However, an investigation was performed.A force to failure test was conducted using a 10-piece sample from a different lot number.Results showed to be within specification.

• Brand Name: SS WHITE CARBIDE BUR
• Common Device Name: DENTAL BUR
• Manufacturer (Section D): SS WHITE BURS LLC; 1145 towbin ave; lakewood 08701
• Manufacturer (Section G): SS WHITE BURS LLC; 1145 towbin ave; lakewood 08701
• Manufacturer Contact: mariam sawaqed ; 1145 towbin ave; lakewood 08701
• MDR Report Key: 22568901
• Report Number: 2245654-2025-00012
• Device Sequence Number: 9237986
• Product Code: EJL
• UDI-Device Identifier: D690300242
• UDI-Public: D690300242
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: HP-PBUR-SC702LA
• Device Catalogue Number: 30024
• Device Lot Number: LO4L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown