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

Model Number 311910115E

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been received and is pending evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported ¿the reported product [bur] was used with normal usage.Unusual materials were came out from the bar tip every time when the reported bar was rotated.¿ the customer further reported the material looked like gray ¿chips¿ and were successfully and completely retrieved.The procedure was completed with backup product.There was no injury reported.

Manufacturer Narrative

Condition upon receipt: 1 un-sealed sample, part number 311910115e, from lot number 0209566204 received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings).Evaluation: when compared to the assembly drawing: when viewed under magnification, there was some minor wear to the fine diamond grit however this is unlikely to have been noticeable due to the head diameter and extent of wear; just proximal to the head, the shaft was gouged and when mixed with other fluids may have appeared as a dark colored liquid emitting from the end of the outer tube.The gouging of the shaft corresponds to the distal end of the outer tube and supports the tip during use.The information indicates the damage occurred during use.The instructions for use warns that excess pressure applied to the bur may cause damage [excess: exceeded sufficient pressure required for operation].Based on the wear to the bur head and shaft, excess pressure was applied to the bur during use.Actual device evaluated.(b)(4).

• 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: charlotte ayala ; 6743 southpoint dr n; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 5545457
• MDR Text Key: 41820224
• Report Number: 1045254-2016-00104
• Device Sequence Number: 1
• Product Code: EQJ
• 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: 03/10/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2019
• Device Model Number: 311910115E
• Device Catalogue Number: 311910115E
• Device Lot Number: 0209566204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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