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

Model Number	1883673HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened sample, part number (b)(4), from lot number 0214264509 was received.Product analysis results: there was a residue consistent with biological contaminants on the device.A portion (approximately half) of the diamond grit was missing which would have resulted in the reported event.The diamond grit that became detached includes the plating (possibly nickel) it was attached to.The portion that detached was not returned.The tip shall be diamond plated with 50 / 60 grit.There were no signs of misuse or mishandling.The information most likely indicates there was insufficient adhesion between the components which caused the detachment.There was an out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The bur broke as soon as it contacted bone.There was no patient impact or injury.There were no fragments that needed to be retrieved.The procedure was completed using a back-up device.

• 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: 7566543
• Report Number: 1045254-2018-00229
• Device Sequence Number: 1758607
• Product Code: EQJ
• UDI-Device Identifier: 20721902686201
• UDI-Public: 20721902686201
• 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): 06/04/2018

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: 10/22/2025
• Device Model Number: 1883673HS
• Device Catalogue Number: 1883673HS
• Device Lot Number: 0214264509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1