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

Model Number	1882569HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1882569hs, from lot number 0212822494 was received for analysis.The spiral wrap broke 1.26¿ from the distal tip which would have resulted in the reported malfunction.The spiral wrap was twisted in on itself in a clockwise direction indicating excess torsional loads.The diamond tip of the bur was compacted with biological contaminants which would have required the user to apply excess pressure to the bur to maintain performance, and in turn, excess torsional loads.There was gouging and a thinning of the distal outer tube wall thickness and wear marks on the inner shaft 0.68¿ from the distal face of the inner hub which is consistent with aggressive use.The information most likely indicates aggressive use resulted in excess torsional loads which caused the breakage.There was an out of specification condition identified as it relates to the complaint (due to physical damage).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The bur broke after 20 minutes of using.There was no patient impact or injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information indicated the tip of the bur broke.It was confirmed that the breakage did not result in fragments.There were no fragments that needed to be retrieved; no fragments fell into the patient.Another bur was used and completed the surgery.

• 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: 7784038
• Report Number: 1045254-2018-00372
• Device Sequence Number: 10806445
• Product Code: EQJ
• UDI-Device Identifier: 20721902978009
• UDI-Public: 20721902978009
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: 02/17/2021
• Device Model Number: 1882569HS
• Device Catalogue Number: 1882569HS
• Device Lot Number: 0212822494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1