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

Model Number 1883672HS

Device Problem Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2015

Event Type  Injury  

Event Description

It was reported that while performing a lothrop procedure, 3 burs (all same part number and lot number) broke during the case.The breaks were at the ¿junction of the tip and spiral shaft¿, with one of the tips breaking off.The fragment was successfully retrieved using forceps.There was no patient impact.

Manufacturer Narrative

Blank fields on this report are the result of information not being provided by initial reporter.This device is used for therapeutic purposes.(b)(4).

Manufacturer Narrative

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 north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4684854
• MDR Text Key: 5670512
• Report Number: 1045254-2015-00118
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0209187816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/13/2015
• Supplement Dates Manufacturer Received: 03/19/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00060 YR
• Patient Weight: 91