MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. HIGH SPEED CURVED DIAMOND BUR; BUR, EAR, NOSE AND THROAT

Model Number 1885076HSE

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

During endoscopic sinus surgery, surgical team using high speed curved diamond bur on microdebrider in patient, when tip of bur broke and bent to the side.Inner portion of tip was still inside base of bur when removed, thus holding the entire supply piece together.

• Brand Name: HIGH SPEED CURVED DIAMOND BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 13633675
• MDR Text Key: 286352526
• Report Number: 13633675
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/20/2022

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: Other
• Device Model Number: 1885076HSE
• Device Lot Number: 0219387550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: Black Or African American