MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - STYLUS TRANSNASAL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	TN30MFL
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No analysis possible as device has not been returned.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A customer reported that the surgeon attempted to use the bur but the head of the drill would not spin.The top of the bur head had disconnected from the base and was broken.The bur was not used on the patient so there was no patient harm.

• Brand Name: XPS® BUR - STYLUS TRANSNASAL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7475160
• Report Number: 1045254-2018-00181
• Device Sequence Number: 19136826
• Product Code: ERL
• UDI-Device Identifier: 00613994776211
• UDI-Public: 00613994776211
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 04/11/2019
• Device Model Number: TN30MFL
• Device Catalogue Number: TN30MFL
• Device Lot Number: 0214226850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR