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	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part 1883070hs from lot number 0209221477 was received with a residue consistent with biological contaminants on the device.A microscope and calipers were used to evaluate the device.Visually, the inner tip was broken off at the distal end of the spiral wrap which would have resulted in the reported event.The spiral wrap was twisted in on itself in a clockwise direction, which indicates excess torsional load.The remaining portion of the inner assembly within the outer assembly spun freely by hand.The length of the detached component from tip to break was approximately 0.69¿.There was gouging and thinning of the distal end of the outer tube wall which is an indication of aggressive use (bending / prying).There was corresponding gouging just proximal to the inner tip.The customer indicated the tip broke off during use with no allegation of a defect prior to use.The reported issue of a broken tip was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during a procedure, the tip of the hi-speed bur broke off.There was no patient impact as a result of the damage.

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7430486
• Report Number: 1045254-2018-00160
• Device Sequence Number: 16683429
• Product Code: EQJ
• UDI-Device Identifier: 20681490464608
• UDI-Public: 20681490464608
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 04/13/2018

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: 02/02/2023
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0209221477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/13/2018
• Patient Sequence Number: 1