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

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

We originally reported 2 burs on mdr 1045254-2016-00374.A supplemental report for the product analysis to 1045254-2017-00342 was provided regarding the first bur, information on the other bur is being submitted in this report.This is 1 of 1 subsequent reports to be filed.Product evaluation: the hi speed diamond 70deg bur, part number 1883672hs, from lot number 0209955643, was received for analysis.There was a residue consistent with biological contaminants on the devices.Biological contaminants were found to be compacted in the diamond grit which likely resulted in the customer applying excess pressure to the bur in an attempt to maintain performance.When viewed under magnification there was evidence of aggressive use; gouging of the outside diameter of the inner shaft just proximal to the tip; and corresponding damage to the outer tube support area (including a thinning of the wall).Visually, the inner assembly tip was stretched out of the outer tube support area which would have resulted in the reported event.The spiral wrap was twisted in on itself in a clockwise direction.The location of the damage is consistent with excessive torsional load between the gouged area of the inner shaft and the spiral wrap proximal to the damage.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information found during the product analysis: the spiral wrap stretched and the tip detached from the first bur; the spiral wrap stretched but remained intact for the second bur.

• Brand Name: XPS® BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7374780
• MDR Text Key: 103831236
• Report Number: 1045254-2018-00132
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1