MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE BUR; SIDE CUTTING CARBIDE BUR

Model Number ZB-104

Device Problem Break (1069)

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

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

Discarded by facility.

Event Description

Facility reported that two (2) burs broke during wisdom teeth removal.Facility confirmed there were no patient injuries in this incident.The devices were not returned by the facility as they were discarded during surgery.The incoming inspection records were reviewed for the lot by our senior quality engineer.In addition, the supplier's production, inspection records and certifications were reviewed.All required check points and dimensions were found to be within specification limits.A review of the vendor's records found no adverse conditions.Based off of knowledge of the procedure, it is likely that excessive force was used.

• Brand Name: MICROAIRE BUR
• Type of Device: SIDE CUTTING CARBIDE BUR
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer Contact: donna elliott ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758370
• MDR Report Key: 5582958
• MDR Text Key: 43518241
• Report Number: 2020601-2016-00009
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 07/30/2019
• Device Model Number: ZB-104
• Device Catalogue Number: ZB-104
• Device Lot Number: 0715274939
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1