MAUDE Adverse Event Report: S.S. WHITE BURS, INC. SS WHITE ITEM #30025 703 LENGTH 51MM LOT NUMBER: 2017-11-03; BUR, DENTAL

Model Number ITEM #30025

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

Patient was being treated on 25 apr 2018 for ext of #1,16,17, 32 with iv sedation.Upon sectioning, removing the distal half of #32, and elevating the mesial half of #32, it was determined that a purchase point would need to be placed in order to deliver the remaining part of the impacted wisdom tooth (#32).During the placement of the purchase point (utilizing a 51mm length 703 bur on a straight surgical hand place) the bur sheared off from the rest of the shank.The remaining bur was visualized and the mesial half of the wisdom tooth was elevated and removed without incident.On the procedure table, the bur was confirmed to be safety outside of the table.After the procedure was completed, the ss white item #30025 703 length 51mm lot number: 2017-11-03 was recorded.Fda safety report id# (b)(4).

• Brand Name: SS WHITE ITEM #30025 703 LENGTH 51MM LOT NUMBER: 2017-11-03
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): S.S. WHITE BURS, INC.
• MDR Report Key: 8944644
• MDR Text Key: 156332134
• Report Number: MW5089419
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ITEM #30025
• Device Lot Number: 2017-11-03
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR