MAUDE Adverse Event Report: COLTENE WHALEDENT INC. SIMPLE PREP CARBIDE; CARBIDE BUR

Catalog Number RL100245

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Bur head breaks off.Bur broke while using on patient.Doctor could not find broken tip patient was sent to have xrays to make sure tip was not swallowed.No surgical intervention was required.On (b)(6) 2022 additional information was provided: female (b)(6).Chest x-ray found nothing.Doctor said that he thinks they found the broken tip but was not for sure.This is why they did chest x-ray for patient safety.

Manufacturer Narrative

Investigation: (b)(4) units of this kit were put to stock in september 2021.There are no units remaining.Complaint analysis for the last 12 months identifies no additional complaints for this product.No product has been returned for investigation.These kits were packaged with semi-finished burs 50008508 k91987.This batch record was reviewed.All dimensional requirements and the functional test for neck strength were met.The customer complaint cannot be confirmed.Root cause: no true root cause could be identified in this complaint.Possible root causes include: the burs may have been damaged upon arrival to the customer but the customer may not have noticed prior to using the product.The burs may have been used multiple times and the flute edges may have been worn.Using a bur with excessive wear may cause the bur to break or cause injury.Cold disinfectant solutions may have been used that contain corrosive agents that degrade the performance and strength of the carbide burs.The burs may not have been stored in a moisture free environment.The burs may have been used with heavy transverse cutting pressure.

• Brand Name: SIMPLE PREP CARBIDE
• Type of Device: CARBIDE BUR
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer (Section G): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: tricia cregger ; 235 ascot parkway; cuyahoga falls, OH 44223
• MDR Report Key: 13446441
• MDR Text Key: 288293706
• Report Number: 2416455-2022-00001
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: RL100245
• Device Lot Number: K99739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female