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

Model Number 1882569HS

Device Problems Overheating of Device (1437); Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7678912
• MDR Text Key: 113904865
• Report Number: 1045254-2018-00289
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00721902978005
• UDI-Public: 00721902978005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1