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

Model Number	SP14MH30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; product was not returned for analysis.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 physician reported that the bur tip broke off during the procedure.The surgeon was not drilling at the time of the event, the surgeon was prying the bur like a curette in the patient.There were no fragments in the patient.Another bur was used to complete the procedure.There was no patient impact.

• Brand Name: XPS® CLEARVIEW - LEGEND TOOL
• 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: 6821691
• Report Number: 1045254-2017-00293
• Device Sequence Number: 1600400
• Product Code: ERL
• UDI-Device Identifier: 00643169308428
• UDI-Public: 00643169308428
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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: 10/18/2020
• Device Model Number: SP14MH30
• Device Catalogue Number: SP14MH30
• Device Lot Number: 0212160704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1