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

Model Number 1884380EM

Device Problem Vibration (1674)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported that during endoscopic sinus surgery a blade's tip part was oscillating from the beginning.Re connection was performed several times, but the tip was oscillating when rotating.The procedure was completed with backup product(s) with no delay.There was no patient impact.

Manufacturer Narrative

The product analysis result indicates that inner assembly would spin, and middle would index freely by hand with no unusual resistance.There was no damage to the tip however the inner shaft was bent just distal to the inner hub which would have resulted in the wobbling.When viewed under magnification, there was damage to the hubs that is consistent with improper or difficulty loading the device into the handpiece: dimples on the front hub prior to the locking area caused by a misalignment of the handpiece locking mechanism; locking area deformation caused by the back side of the front collet of the handpiece; and deformation of the proximal inner hub chevrons caused by the handpiece drive mechanism.There were no loose components.Even with the deformation of the hubs, functionally the device loaded securely into a handpiece ran at 5,000 rpm in oscillate mode/direction but wobbled as reported.A review of the xpi did not indicate any evidence to point to improper manufacturing and there are checks for damage throughout the process.A bur or blade that is not properly loaded would result in improper support from the handpiece, engagement with the suction seal, drive, and locking mechanism.The complaint was confirmed.In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage).The most likely underlying cause is consistent with, misuse / use error.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® SYSTEM NAVIGATED 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: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9416428
• MDR Text Key: 169356306
• Report Number: 1045254-2019-00651
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130608
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0218473300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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