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

Model Number	1883673HS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the bur found that visually, the spiral wrap broke.The break location corresponds to the distal end of the outer tube.The spiral wrap was twisted in on itself in a clockwise direction.The detached portion measured 0.462¿ long.The inner shaft was worn 0.63¿ from the distal face of the inner hub and the hub bushings were gouged.The wear corresponds to the proximal end of the outer tube in the front hub.The inside diameter of the distal end of the outer tube was worn through with gouging.There were biological contaminants compacted into the diamond grit.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The health care provider (hcp) reported via manufacturer representative that during endoscopic sinus surgery while drilling was performed in the nasal cavity, it seemed that force was applied and the tip of the bur broke.The tip of the bur was broken in the maxillary sinus of the nasal cavity and tip came off.The broken tip was taken out immediately by aspiration.There was a procedure delay of 10 minutes and was completed using a backup product.No broken pieces of the bur remained in the patients body.There was no patient impact.

• 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: 7878038
• Report Number: 1045254-2018-00431
• Device Sequence Number: 16188489
• Product Code: EQJ
• UDI-Device Identifier: 20721902686201
• UDI-Public: 20721902686201
• 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): 09/14/2018

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: 08/28/2025
• Device Model Number: 1883673HS
• Device Catalogue Number: 1883673HS
• Device Lot Number: 0213936395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1