MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - IPC® M5 AND M4 30K; BUR, EAR, NOSE AND THROAT

Model Number	1883070BLC
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned.However, the product analysis has not yet been completed.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
It was reported that the bur was not cutting properly during the procedure.Additional information received indicates that shavings came off the bur and there was no patient impact.
Additional Manufacturer Narrative
Date rec'd by mfr: jan/20/2017.The product analysis indicates that one unsealed sample and 3 sealed samples of part number 1883070blc from lot number 0210761146 were received.The inner assembly of the unsealed sample turned freely by hand.A microscope, ipc console in conjunction with an m4 handpiece were used to analyze the device.Visually with an unaided eye, just behind the tip of the bur there appeared to be pieces, which would have confirmed the complaint.However, when viewed under high magnification the pieces were actually biological contaminants coming out from between the inner and outer assemblies (no device shavings were found).Functionally, the bur was run at 12,000 rpm in forward direction while viewing the tip under a microscope.No shavings were found during or after the function test, only biological material.The device would cut saw bone with no issues.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The outer assembly had minor abrasions at the distal end, which were consistent with marks from the bending process during manufacturing.These abrasions were not significant enough to result in device shavings.The information most likely indicates a perceived issue due to the biological contaminants coming from between the assemblies, or, the minor abrasions observed on the outer tube.The reported issue could not be confirmed.The device condition was in specification as it relates to the complaint.One sealed sample was opened for the analysis and tested in the same fashion as the un-sealed sample.There were no performance issues or shavings identified.(b)(4).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - IPC® M5 AND M4 30K
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6247654
• Report Number: 1045254-2017-00021
• Device Sequence Number: 19050964
• Product Code: EQJ
• UDI-Device Identifier: 00643169434608
• UDI-Public: 00643169434608
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2016

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: 01/31/2018
• Device Model Number: 1883070BLC
• Device Catalogue Number: 1883070BLC
• Device Lot Number: 0210761146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided; 01/20/2017
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/14/2017; 09/28/2017
• Patient Sequence Number: 1