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

Model Number	31151098E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.  a follow-up report will be submitted when analysis is complete.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 the tip of the bur snapped off and was left in the patients middle ear during a cochlear implant procedure.The hcp left the broken tip as it would be too dangerous for the other structures.The procedure was completed without the use of a back-up device.The procedure was delayed for 60 minutes due to the need for xray confirmation.The broken tip was confirmed to still be in the middle ear via xray.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from the healthcare professional (hcp) reported there has been no symptoms associated with the piece of the bur that remained inside the patient's middle ear.
Additional Manufacturer Narrative
Analysis found that visually, the tip had broken off.The portion that became detached was not returned however it would have measured approximately 0.12¿ x 0.04¿.When viewed under magnification, the configuration of the fracture was consistent with shear or bending stress.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: 8110369
• Report Number: 1045254-2018-00659
• Device Sequence Number: 13886293
• Product Code: EQJ
• UDI-Device Identifier: 00885074322162
• UDI-Public: 00885074322162
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Followup
• Report Date (Section B): 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: 31151098E
• Device Catalogue Number: 31151098E
• Device Lot Number: 0215072934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/12/2018; 03/12/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/10/2019; 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention