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

Model Number	1883670HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bur has not been returned for evaluation.
Event or Problem Description
The customer reported three high speed burs broke within thirty seconds of use during a procedure.This report represents bur 1 of 3.
Additional Manufacturer Narrative
The product analysis indicates two opened samples of part number 1883670hs from lot number 0209944308 were received for evaluation.The returned samples were the same part / lot number and packaged together.It could not be determined which sample went with which regulatory report.The samples were analyzed together, and the results duplicated on each supplemental mdr.A microscope and calipers were used to evaluate the burs.Sample 1: the spiral wrap was stretched by ¼¿ which caused the inner assembly to protrude out of the outer tube support area.Sample 2: there was a fibrous green mat attached to the tip of the bur, however this is not likely to have contributed to the complaint.The locking area was deformed in such a way that indicates excess torsional load which may or may not have contributed to the complaint.Both samples: showed no signs of a break (raw materials separated), no detachment of components, and no heat discoloration.The distal end of the outer tubes was worn and gouged which is an indication of aggressive use such as prying or pushing to remove material during dissection.There was no allegation of a defect prior to use.The information most likely indicates axial bending / prying load from use, combined with excess pressure caused friction which resulted in the wear and gouging.Bur 1 of 3, regulatory report #:1045254-2017-00493 bur 2 of 3, regulatory report #: 1045254-2017-00494 bur 3 of 3 was not returned for evaluation, regulatory report #: 1045254-2017-00495.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7148831
• Report Number: 1045254-2017-00493
• Device Sequence Number: 11176560
• Product Code: EQJ
• UDI-Device Identifier: 20681490692810
• UDI-Public: 20681490692810
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: 1883670HS
• Device Catalogue Number: 1883670HS
• Device Lot Number: 0209944308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/22/2018
• Patient Sequence Number: 1