MAUDE Adverse Event Report: MEDTRONIC-XOMED HIGH SPEED TAPERED DIAMOND BURR; BUR, EAR, NOSE, THROAT

Model Number 4MM 70 DEGREE

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

During endo sinus drilling, nine drills broke: five of the high speed tapered diamond burr 4mm 70 degree (ref # 1883672hs).Two of the high speed rad frontal fine sse burr 3mm 40 degree (ref # 1883070hs).Two of the high speed tapered diamond choanal 4mm 15 degree (ref # 1883673hs).Additional devices were obtained and the procedure was completed without further incident.

Event Description

During endo sinus drilling, nine drills broke: five of the high speed tapered diamond burr 4mm 70 degree (ref#1883672hs).Two of the high speed rad frontal fine sse burr 3mm 40 degree (ref#1883070hs).Two of the high speed tapered diamond choanal 4mm 15 degree (ref#1883673hs).Additional devices were obtained and the procedure was completed without further incident.

• Brand Name: HIGH SPEED TAPERED DIAMOND BURR
• Type of Device: BUR, EAR, NOSE, THROAT
• Manufacturer (Section D): MEDTRONIC-XOMED; 6743 southpointe drive north; jacksonville FL 32216
• MDR Report Key: 3925137
• MDR Text Key: 4518330
• Report Number: 3925137
• Device Sequence Number: 5
• Product Code: EQJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/03/2014
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 4MM 70 DEGREE
• Device Catalogue Number: 1883672HS
• Device Lot Number: HG046DQ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR