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

Model Number	3155648
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9770476
• Report Number: 1045254-2020-00121
• Device Sequence Number: 643178
• Product Code: EQJ
• UDI-Device Identifier: 00681490070584
• UDI-Public: 00681490070584
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 06/20/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1