MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - UNKNOWN; BUR, EAR, NOSE AND THROAT

Model Number XOM UNKNOWN BUR

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Analysis found the broken bur is stuck in the nose cone.If information is provided in the future, a supplemental report will be issued.

Event Description

The device was returned with no information.There was no patient involvement.

Manufacturer Narrative

Visually, the bur was broken into at least two pieces.The break point was consistent with being bent until broken and there were tool marks present.There was excess wear to the tang.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from service and repair that the drill head was broken and noting that only the bur base half remained stuck in the drill.

• Brand Name: XPS® BUR - UNKNOWN
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 7974078
• MDR Text Key: 123985738
• Report Number: 1045254-2018-00519
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XOM UNKNOWN BUR
• Device Catalogue Number: XOM UNKNOWN BUR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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