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

Model Number XOM UNK BUR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The device was returned with no allegation of malfunction.There was no patient impact.

Manufacturer Narrative

Analysis found that bur was broken into at least three pieces, the distal end was not returned.The two pieces measured 3/8¿ and 1-3/8¿.The break points were consistent with being bent until broken and there were tool marks along the length of the two pieces.There was excess wear to the tang.With no damage to the nose cone of the hand piece.If information is provided in the future, a supplemental report will be issued.

Event Description

On follow up, the manufacturer representative reported that event occurred prior to use.

• 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: 8045887
• MDR Text Key: 126531012
• Report Number: 1045254-2018-00569
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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: Health Professional
• Device Model Number: XOM UNK BUR
• Device Catalogue Number: XOM UNK BUR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/11/2019
• 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