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

Model Number 31315066U

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare professional (hcp) reported via a manufacturer representative that a small fragment of the bur was chipped while in use by the surgeon during a mastoidectomy procedure.The surgeon was able to locate and remove the fragment which was easily found from the surgical site.There was only a minimal delay in the procedure due to changing of bur and removing the fragment.There was no patient impact.

Manufacturer Narrative

Analysis found that visually, a chip was taken out of the cutting edge at the tip.The chip was not retuned but would have measured approximately 0.036¿ by 0.012¿.There were multiple indents on the cutting edge of other flutes proximal to the centerline of the cutting tip.If information is provided in the future, a supplemental report will be issued.

• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8196028
• MDR Text Key: 131396264
• Report Number: 1045254-2018-00730
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 20885074524805
• UDI-Public: 20885074524805
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: 31315066U
• Device Catalogue Number: 31315066U
• Device Lot Number: 0213946791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1