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

Model Number	1884068HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.
Event or Problem Description
It was reported that during a procedure, the high speed bur broke at the base (blue hub).There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1884068hs is from lot number 0211715936.There was a residue consistent with biological contaminants on the device.The head of the bur was pushed into the outer tube when received, it was not detached.A microscope and calipers were used to evaluate the device.Visually, the inner shaft broke which would have resulted in the reported event.The break would have been contained by the outer tube and handpiece.The break showed striations around the outside diameter and occurred 0.64¿ from the distal face of the inner hub.This break is typical of excess pressure applied to the bur during use and indicates metal to metal contact with the proximal end of the outer tube.At the distal end, there was gouging of the head support area on the inner and outer assemblies which is also consistent with excess pressure.There was minor deformation of the front hub consistent with aggressive use.There was no allegation of a defect prior to use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED CURVED
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6534802
• Report Number: 1045254-2017-00132
• Device Sequence Number: 324698
• Product Code: EQJ
• UDI-Device Identifier: 20681490692919
• UDI-Public: 20681490692919
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2017

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: 07/30/2024
• Device Model Number: 1884068HS
• Device Catalogue Number: 1884068HS
• Device Lot Number: 0211715936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 04/06/2017; 12/08/2017
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 09/07/2017; 12/22/2017
• Patient Sequence Number: 1