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

Model Number 3155648

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The product analysis result indicates that the cutting tip was detached from the distal end which would have resulted in the reported event.The portion that became detached was not returned but would have measured approximately 1/2¿.The teflon bushings showed deformation and detached; and the shaft showed wear which indicates use.The evidence and biological contaminants are not consistent with the issue occurring before use.The customer insinuated that the tips were damaged upon opening the package however this would have been immediately noticeable to manufacture ¿if¿ the issue were present at that time.The manufacturing instructions require a 100% visual and pull test during production to ensure the tip is securely fastened to the bur assembly.A review of the global complaint data showed no other complaints for either lot identified on this event and no complaints for this part number in the last 12 months; in contrast, this facility reported an issue with both on the same day with the same failure mechanism.The information most likely indicates the damage occurred during use.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.

Event Description

It was reported that pre operatively the devices were broken upon opening it from the sealed pack.Both tips were damaged.There was no patient involvement.Upon follow up it was confirmed that it was the distal tip of the device that was broken, there was no fragment detached.A new bur was used and completed the procedure with around 10minutes of delay.

• Brand Name: XPS® BUR
• 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: 9770476
• MDR Text Key: 183000686
• Report Number: 1045254-2020-00121
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490070584
• UDI-Public: 00681490070584
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3155648
• Device Catalogue Number: 3155648
• Device Lot Number: 0215716710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• 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