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	05/13/2019
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 healthcare provider (hcp) reported that the bur broke from the beginning of its use.Patient is alive-no injury.There was no patient impact.
Additional Manufacturer Narrative
Product analysis: visually, the tip had broken off which would have resulted in the reported event.It was determined that the inner spiral wrap just proximal to the cutting was twisted in on itself in a clockwise direction until breakage occurred which caused the tip to break off.The cutting tip was not returned for analysis.The twist in the spiral wrap is consistent with excess torsional load and the location indicates the load would have been at the cutting tip.The inside diameter of the distal end of the outer tube was rough and worn on one side indicating the directionality of a load and is consistent with aggressive use.There was a residue consistent with grease on the outside diameter of the spiral wrap, grease is required per the drawing.There was minor deformation of the front hub locking area which is consistent with aggressive use.If 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: 8914569
• Report Number: 1045254-2019-00399
• Device Sequence Number: 16832523
• Product Code: EQJ
• UDI-Device Identifier: 20721902100561
• UDI-Public: 20721902100561
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/14/2019

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 Expiration Date: 02/28/2023
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0209313389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1