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

Model Number	1884068HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 when the surgeon started the shaver prior to the procedure, the bur was broken.A different bur was used for the procedure.There was no patient involvement.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the health care provider (hcp) reported via a manufacturer representative that there was no delay in the case, just a change of the bur for dacryocystorhinostomy procedure.
Additional Manufacturer Narrative
Analysis found that the inner shaft broke 0.625¿ from the distal face of the inner hub.There were striations around the outside diameter of the break point indicating metal on metal contact during use.The break point corresponds to the proximal end of the outer tube in the front hub.There was no damage to the distal tip.When viewed under magnification, there was deformation and indentations of the front hub locking area.There were no bends or signs of a concentricity issues.There was no indication of device fragments.There were no signs of heat deformation or discoloring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED CURVED
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8013932
• Report Number: 1045254-2018-00542
• Device Sequence Number: 16459477
• Product Code: EQJ
• UDI-Device Identifier: 20681490692919
• UDI-Public: 20681490692919
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2018

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: 09/02/2022
• Device Model Number: 1884068HS
• Device Catalogue Number: 1884068HS
• Device Lot Number: 0208716334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 10/31/2018; 12/14/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1