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

Model Number	1884566
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the bur completely dismantled during the procedure.The device was used as per the product manual using a handpiece in a rhinoplasty case.The inner shaft of the bur broke after 3 minutes of use.There was no device fragmentation since the breakage was internal.There was no delay in the procedure and there were no additional non-routine actions performed or required as a result of the event.The case was completed using a back-up device.There was no patient impact or injury.
Additional Manufacturer Narrative
Analysis found that the inner shaft of the device broke 0.66¿ from the distal face of the inner hub.There were striations around the outside diameter of the break point which corresponds to the proximal end of the outer tube in the front hub.The inner hub washer had come off the assembly.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.There were biological contaminants compacted in the flutes of the cutting tip.When viewed under magnification, the proximal end of the inner hub was worn down.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7968868
• Report Number: 1045254-2018-00514
• Device Sequence Number: 16587900
• Product Code: EQJ
• UDI-Device Identifier: 20681490047733
• UDI-Public: 20681490047733
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/13/2018

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: 08/22/2024
• Device Model Number: 1884566
• Device Catalogue Number: 1884566
• Device Lot Number: 0211848030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1