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

Model Number	1884068HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that six high-speed burs broke at the base of each bur during a procedure.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED CURVED
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6372159
• Report Number: 1045254-2017-00072
• Device Sequence Number: 13710916
• Product Code: EQJ
• UDI-Device Identifier: 20681490692919
• UDI-Public: 20681490692919
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: 03/27/2024
• Device Model Number: 1884068HS
• Device Catalogue Number: 1884068HS
• Device Lot Number: 0211041844
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 09/29/2017
• Patient Sequence Number: 1