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

Model Number	311920115E
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation was performed as the device was discarded by the customer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A customer reported via a manufacturer representative that two of three burs broke during a procedure.Another bur didn't have any issue.The broken curved burs were used with a "raking" like movement.The physician commented that the load that was applied to the burs was considered to be the cause of the breakage of the burs.The burs were used for approximately 10 minutes and it was confirmed that the breakage did not occur immediately.The physician claimed there was a little bit of dissatisfaction because the way the burs were being used was not so extreme.The broken pieces were removed by suction and it was visibly confirmed that no pieces remained in the surgical field.The broken burs were discarded by the facility.No patient impact was reported.

• 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: 7524722
• Report Number: 1045254-2018-00206
• Device Sequence Number: 11122393
• Product Code: EQJ
• UDI-Device Identifier: 00885074154039
• UDI-Public: 00885074154039
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/17/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 311920115E
• Device Catalogue Number: 311920115E
• Device Lot Number: 0214920677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1