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

Model Number	1883672HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2018
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 broke during a surgery on the nasopharyngeal fibroma.The surgeon drilled for 5 to 10 minutes at the back wall of maxillary sinus.There was a 10 to 15 minutes procedure delay because the surgeon changed the bur with a new one.The procedure was completed using a back-up device.The hcp noted that this was the initial use of the device.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that the inner cutting tip broke off at the distal end of the spiral wrap.The portion that became detached measured 0.465¿.The spiral wrap was twisted in on itself in a clockwise direction at the break point which indicates excessive torsional load.The inside diameter of the outer tube was gouged with a thinning of the wall at the distal end however it was only on one side which is indication of shear stress.There was corresponding damage to the inner assembly.The diamond grit and the irrigation port were compacted with biological contaminants.The front hub showed deformation consistent with improper loading; dimples on the front hub prior to the locking area caused by a misalignment of the handpiece locking mechanism; and locking area deformation caused by the back side of the front collet of the handpiece.Information is provided in the future, a supplemental report will be issued.

• 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: 8160983
• Report Number: 1045254-2018-00710
• Device Sequence Number: 11313581
• Product Code: EQJ
• UDI-Device Identifier: 00721902100567
• UDI-Public: 00721902100567
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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 Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0214833856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1