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

Model Number	1882569HS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no loose components.There was gouging and significant wear on the inside diameter of the distal outer tube and corresponding location on the inner shaft.Although there was no sign of heat discoloration or deformation of the plastic components; the wear and gouging of the distal end would have resulted in friction and likely to produce heat.The extent of wear resulted in, an increase in clearance between the inner and outer assemblies, which would have resulted in wobbling.The hub bushings were gouged / worn which is an indication of excess pressure being applied to the bur while in use and / or excess speed.This device has a maximum recommended speed of 12,000 rpm.The spiral wrap was stretched by approximately 1¿ which is likely only a symptom of the damage observed above.The information most likely indicates that bending / prying / aggressive use resulted in the gouging and wear of the bur, which caused the reported heat and wobble.Complaint substantiated / confirmed: yes.Conclusion: there was an out of specification condition identified as it relates to the complaint (due to physical damage).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During use, the bur over-heated and the shaft wobbled.This is a brand new bur.There was no patient impact or injury.The procedure was completed with back-up product.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7678912
• Report Number: 1045254-2018-00289
• Device Sequence Number: 16507121
• Product Code: EQJ
• UDI-Device Identifier: 00721902978005
• UDI-Public: 00721902978005
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 12/04/2021
• Device Model Number: 1882569HS
• Device Catalogue Number: 1882569HS
• Device Lot Number: 0214527367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1