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

Model Number	312120115E
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: the visao 2mm bur was received for analysis.Visually, the shaft broke just proximal to the cutting tip which would have resulted in the reported event.The portion that became detached measured 0.125¿.The break configuration is consistent with shear or bending stress.The inside diameter of the outer tube (distal end) was excessively worn on one side.There was wear to the inner assembly shaft the corresponds to the wear on the outer tube.The customer indicated the break occurred during the procedure but there was no evidence of wicking into the cooling sleeve which may indicate the device was not being irrigated per the instructions.The information most likely indicates aggressive use resulted in the excess wear to the outer tube and subsequent breakage next to the wear.The lack of irrigation on the cooling sleeve may have also contributed to the observed damage.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 an ess procedure the tip of the bur broke off.There were no fragments that needed to be retrieved and none left in the patient.There was no patient impact.

• Brand Name: XPS® BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6931453
• Report Number: 1045254-2017-00352
• Device Sequence Number: 19145212
• Product Code: EQJ
• UDI-Device Identifier: 00885074322254
• UDI-Public: 00885074322254
• 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
• Report Date (Section B): 09/15/2017

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: 12/07/2020
• Device Model Number: 312120115E
• Device Catalogue Number: 312120115E
• Device Lot Number: 0212449786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1