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

Model Number	1883670HS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available; device not returned for evaluation, discarded by user 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 surgeon reported that during a draf iii procedure the "inner rod was drawn" on the first bur.A backup bur was used to continue with the procedure; however, the "inner rod broke.The end of the bur was ejected into the bottom of the frontal sinus." surgical time was extended slightly to remove the fragment.It was confirmed that the fragment was successfully retrieved and the patient is well, no impact.
Additional Manufacturer Narrative
Product evaluation: received 1 opened sample, part number 1883670hs, from lot number 0210864805, for analysis.Visually, the inner spiral wrap was twisted in on itself in a clockwise direction until breakage occurred which would have resulted in the reported event.The breakage is an indication of excess torsional load.The distal end of the inner assembly was not returned.The distal end of the outer tube was worn and gouged which is indication of aggressive use such as prying or pushing to remove material during dissection.There was no allegation of a defect prior to use.The information most likely indicates torsional load from use, combined with excess pressure caused friction which resulted in the wear, gouging, and the subsequent break.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received: it was initially believed that the facility had discarded the burs; however, they had been given to the pharmacist for return and have since been received.It was also confirmed that there were 2 burs that had the "inner rod drawn"; a total of 3 burs were used for the procedure.This mdr was filed to report the bur that had the detached tip that required retrieval.

• 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: 6835809
• Report Number: 1045254-2017-00300
• Device Sequence Number: 1600564
• Product Code: EQJ
• UDI-Device Identifier: 00681490692816
• UDI-Public: 00681490692816
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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: 02/20/2024
• Device Model Number: 1883670HS
• Device Catalogue Number: 1883670HS
• Device Lot Number: 0210864805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1