MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. HIGH SPEED TAPERED DIAMOND BURR; HIGH SPEED TAPERED DIAMOND BURR. 4MM

Lot Number 0208854558

Device Problem Break (1069)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/14/2015

Event Type  malfunction  

Event Description

Patient undergoing sinus surgery, endoscopic repair of skull base defect, advanced frontal sinus exploration with removal of bone and tissue from the anterior cranial fossa, left maxillary antrostomy.During this procedure, one of the burrs used, broke.There were no retained objects and no complications as a result.Reason for use: recurrent cerebrospinal fluid leak after previous repair.Ndc # or unique id: (b)(4).

• Brand Name: HIGH SPEED TAPERED DIAMOND BURR
• Type of Device: HIGH SPEED TAPERED DIAMOND BURR. 4MM
• Manufacturer (Section D): MEDTRONIC XOMED, INC.
• MDR Report Key: 5350719
• MDR Text Key: 35377563
• Report Number: MW5059008
• Device Sequence Number: 1
• Product Code: EQJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Lot Number: 0208854558
• Other Device ID Number: 1883672HS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 88