MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. N/A; BUR, EAR, NOSE AND THROAT

Model Number 1883673HS

Device Problems Break (1069); Material Fragmentation (1261); Device Inoperable (1663)

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

Event Date 01/04/2018

Event Type  malfunction  

Event Description

During the case we opened up multiple burs (bur choanal atresia 4mm 15 de (b)(4)) to be used with the xomed sinus shaver and they malfunctioned during use.We contacted the rep for the device and sent away the defective burs to our inventory specialist.While the m5 xomed shaver hand piece was in use, the choanal atresia bur broke into 2 pieces.This happened with 2 different burs, both having the same lot number.

• Brand Name: N/A
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jacksonville FL 32216
• MDR Report Key: 7316938
• MDR Text Key: 101629704
• Report Number: 7316938
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1883673HS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR