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

Model Number	1884075HSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; product was not returned for analysis.The device was discarded by the facility.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
The facility reported that the bur was broken during the procedure.There was no patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received indicating that the break occurred at the end of the device.The break did not result in any fragments inside the patient.The procedure was completed with another bur.
Additional Manufacturer Narrative
Corrected information: no eval explain code.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: 6687600
• Report Number: 1045254-2017-00219
• Device Sequence Number: 880665
• Product Code: EQJ
• UDI-Device Identifier: 00613994233189
• UDI-Public: 00613994233189
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2017

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: 09/14/2020
• Device Model Number: 1884075HSE
• Device Catalogue Number: 1884075HSE
• Device Lot Number: 0211976603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/28/2017; 07/28/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 08/22/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1