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	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates that one unsealed sample of 1883070hs from lot number 0210035015 was received.There was a residue consistent with biological contaminants on the device.A microscope and calipers were used to evaluate the bur.The spiral wrap was stretched and broke off at the distal end of the inner assembly, which would have resulted in the reported event.The length of portion the broke off measured 1.9¿ in a free state.The spiral wrap was twisted in on itself in a clockwise direction, which likely indicates excess torsional load.There was gouging at the distal end of the inner cuter outside diameter and the inside diameter of the outer tube, which corresponds the support area for the tip.The gouging resulted in excess wear to the support area of the outer tube, which caused a thinning of the wall thickness and is consistent with excess pressure.The remainder of the inner assembly spun freely within the outer assembly.The customer indicated that the device malfunctioned during the procedure with no indication of damage / defect prior to use.There was biological contaminants compacted in the flutes, which likely would have reduced the cutting performance and may have contributed to the observed damage.
Event or Problem Description
It was reported that a high speed bur broke during a procedure.There was no patient injury.
Additional Manufacturer Narrative
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
Additional information received indicates that this event occurred during a bariatric (gastric sleeve) procedure.The user also confirmed that no piece(s) detached from the device and fell into the patient.

• 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: 6300936
• Report Number: 1045254-2017-00046
• Device Sequence Number: 1610711
• Product Code: EQJ
• UDI-Device Identifier: 20681490464608
• UDI-Public: 20681490464608
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/09/2017

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: 08/22/2023
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0210035015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 03/24/2017
• Patient Sequence Number: 1