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

Model Number	31315066U
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative that a small fragment of the bur was chipped while in use by the surgeon during a mastoidectomy procedure.The surgeon was able to locate and remove the fragment which was easily found from the surgical site.There was only a minimal delay in the procedure due to changing of bur and removing the fragment.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that visually, a chip was taken out of the cutting edge at the tip.The chip was not retuned but would have measured approximately 0.036¿ by 0.012¿.There were multiple indents on the cutting edge of other flutes proximal to the centerline of the cutting tip.If information is provided in the future, a supplemental report will be issued.

• 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: 8196028
• Report Number: 1045254-2018-00730
• Device Sequence Number: 1653051
• Product Code: EQJ
• UDI-Device Identifier: 20885074524805
• UDI-Public: 20885074524805
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 08/30/2021
• Device Model Number: 31315066U
• Device Catalogue Number: 31315066U
• Device Lot Number: 0213946791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1