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

Model Number 31181598E

Device Problems Break (1069); Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.Device evaluation is not complete; evaluation is in progress.The device was visually inspected.Tissue was attached to the distal tip and shaft.Some of this tissue is burned black.The distal tip is burned out.The distal tip is fixed to the outer tube of the blade.Shaft was fractured near the tip.Device evaluation is not complete at this time, completion of evaluation is anticipated.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the device tip was burned and the shaft of the bur came off.There was no report of patient injury.

Manufacturer Narrative

Device evaluation has been completed.The discoloration of the tip was consistent with being heat related and the shaft did not turn the head which would have resulted in the reported event.The tip was stuck to the distal end of the outer tube.Nominally there is a 0.027¿ gap between the head and outer tube when the bur is loaded properly in the handpiece.The proximal end of the shaft and tang assembly was removed which measured 3.825¿ from end to end.The break point was mushroomed out which is consistent with either impact, or continuous rotation after the break.The shaft near the break was gouged.There were trace amounts of biological contaminants on the nylon cooling thread however there was no evidence of wicking, a capillary action, most likely indicting wetting was not maintained during use per the ifu.There was no evidence of the observed damage occurring, or the result of a manufacturing def ect therefore has been ruled out as a likely cause.The information most likely indicates the bur head made contact with the outer tube as the result of an improperly seated hub which caused the discoloration and the distal end of the inner assembly to seize which then caused the shaft breakage.The ifu states in bur installation to firmly push the curved bur hub onto the handpiece until it snaps in place.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR
• 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: sharanya jangiti ; 6743 southpoint dr n; jacksonville, FL 32216 ; 9043328183
• MDR Report Key: 6247653
• MDR Text Key: 64735428
• Report Number: 1045254-2017-00022
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074322223
• UDI-Public: 00885074322223
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2016

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 Expiration Date: 05/12/2019
• Device Model Number: 31181598E
• Device Catalogue Number: 31181598E
• Device Lot Number: 0209600828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided; 02/13/2017
• Supplement Dates FDA Received: 02/24/2017; 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1