MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.1MM CROSS-CUT FISSURE ROUND TIP CARBIDE BUR; BUR, DENTAL

Catalog Number	2296101421
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a procedure on the wisdom tooth, three burs made noise and was moving.It was also reported that there was a forty-five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the third bur.
Event or Problem Description
It was reported that during a procedure on the wisdom tooth, three burs made noise and was moving.It was also reported that there was a forty-five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the third bur.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.Device not returned.

• Brand Name: 2.1MM CROSS-CUT FISSURE ROUND TIP CARBIDE BUR
• Common Device Name: BUR, DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8711803
• Report Number: 0001811755-2019-02079
• Device Sequence Number: 2298858
• Product Code: EJL
• UDI-Device Identifier: 04546540046277
• UDI-Public: 04546540046277
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 2296101421
• Device Lot Number: 17205017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1