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

Model Number	1884560HS
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inner shaft broke 0.65¿ from the distal face of the inner hub which would have resulted in the reported malfunction.There were striations around the outside diameter of the break point and various points along the shaft indicating metal on metal contact during use.The break point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there was deformation of the front hub outside diameter and plastic residue consistent with the hub material around the inner shaft break point.The remainder of the inner assembly spun freely by hand within the outer tube.The inner shaft outside diameter shall be (b)(4)¿ and measured (b)(4)¿ which is in specification (in the undamaged area).The outer tube inside diameter shall be (b)(4)¿ and measured (b)(4)¿ which is in specification (in the undamaged area).There were no signs of bends or concentricity issues that would have contributed to the event.The information indicates excess pressure was applied during use which caused the deformation of the hub; which then caused the inner shaft and outer tube to rub together until the inner shaft broke.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A customer reported that the bur was completely attached but was not turning properly.It was noted that there was no procedure delay and no injury to the patient.

• Brand Name: XPS® BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7612989
• Report Number: 1045254-2018-00254
• Device Sequence Number: 16555462
• Product Code: EQJ
• UDI-Device Identifier: 20681490692995
• UDI-Public: 20681490692995
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 03/09/2025
• Device Model Number: 1884560HS
• Device Catalogue Number: 1884560HS
• Device Lot Number: 0212949079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1