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

Model Number 312120115E

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

In response to medtronic¿s request for device return, no device was received for evaluation (detailed as followed): the distal end of the outer tube was ground down in the same shape as the proximal side of the cutting head , indicating the head and outer tube made contact.There were powder abrasions on the proximal end of the grey hub most likely from being improperly seated.The bur was loaded into a handpiece and would not fully seat which resulted in the contact between the components (hub and outer tube orientated closer to the head)¿although the shaft locked into place the grey hub remained over 0.03¿ away from the seated position.This appears to be the result of an improperly seated o-ring holder on the inside of the hub.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 that ¿metallic powder was scattered¿ intraoperatively during a tympanoplasty.The bur did not come into contact with any hard material, such as metal.The metallic powder continuously scattered during use while resecting normal bone.The procedure was successfully completed using the reported product.There was no report of patient impact or injury as a result of this event.

Manufacturer Narrative

The following information was received on october 26, 2016.All the "metallic powder" was retrieved.The "metallic powder" was retrieved from the surgical field.The "metallic powder" was retrieved by suction with an irrigation source.No patient information is available.It was initial use of the device in this event.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.

• 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: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6057818
• MDR Text Key: 58405853
• Report Number: 1045254-2016-00364
• 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,Followup
• Report Date: 09/27/2016

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: 04/18/2020
• Device Model Number: 312120115E
• Device Catalogue Number: 312120115E
• Device Lot Number: 0211144832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/23/2016; 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1