MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. CURVED SINUS BURS; BUR, EAR, NOSE AND THROAT

Model Number 1883070HS

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 09/26/2014

Event Type  malfunction  

Event Description

It was reported that a bur broke during a case.Follow up communication stated ¿surgeon was drilling frontal sinus bone with 40 degree finesse bur and it stopped working.The entire bur would spin around, but not just the bur head.Repositioned it several times in handpiece, and it was not working.¿ there was no injury reported as a result of this event.Another bur style was used to complete the procedure.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The device was discarded by the user facility.Method ¿ no testing methods performed.

Manufacturer Narrative

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

• Brand Name: CURVED SINUS BURS
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 4189357
• MDR Text Key: 5100357
• Report Number: 1045254-2014-00262
• 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,User Facility,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

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 Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 10/21/2014
• Supplement Dates Manufacturer Received: 09/26/2014
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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