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

Model Number	1883070HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: analysis results are not available; the device is being shipped from ous to our us facility.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician reported that during ¿the early step¿ of an ess (endoscopic sinus surgery), ¿the bur was broken.A back-up device was used instead, and the procedure was completed with the back-up device.¿ there was no patient impact.
Additional Manufacturer Narrative
The product analysis indicates one opened sample, part number 1883070hs, from lot number 0213503453 was received.Analysis results indicated that the inner spiral wrap was stretched which resulted in the tip extending beyond the support area of the outer tube (by 0.36¿) which would have resulted in the reported event.Although there was damage to the spiral wrap, the remainder of the inner assembly spun freely by hand.There was gouging and a thinning of the distal outer tube wall thickness which is indicative of excess pressure applied to the bur while in use.There were no loose components.The information most likely indicates that aggressive use resulted in the gouging and wear which increased the torsional load and caused the spiral wrap damage.The device condition was out of specification as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 7141626
• Report Number: 1045254-2017-00479
• Device Sequence Number: 19115780
• Product Code: EQJ
• UDI-Device Identifier: 20681490464608
• UDI-Public: 20681490464608
• 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,Followup
• Report Date (Section B): 01/26/2018

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: 06/13/2025
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0213503453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1