MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR; BUR, EAR, NOSE AND THROAT

Model Number	1883672HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded by the customer.A product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the surgeon was using the burs during a fess procedure, and two burs from the same lot number broke at the spiral wrap.All pieces were retrieved from the patient and no harm was done to the patient.The surgeon used another bur to finish the procedure.This regulatory report is for bur 2 of 2.

• Brand Name: XPS® BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7432488
• Report Number: 1045254-2018-00162
• Device Sequence Number: 1339538
• Product Code: EQJ
• UDI-Device Identifier: 00721902100567
• UDI-Public: 00721902100567
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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: 10/20/2023
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0210321704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1