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

Model Number	1883262HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number (b)(4) from lot number 0211848031 was received.There was a residue consistent with biological contaminants on the device.A microscope, calipers, micrometer, and pin gages were used to evaluate the device.The inner shaft broke 1.32¿ from the distal face of the inner hub which would have resulted in the reported event.There were striations around the break point and the area corresponds to the reduction of the diameter (as designed) in the outer tube.There were also striations around the inner shaft 5/8¿ from the distal face of the inner hub which is consistent with aggressive use.At the outer tube reduced diameter, there was discoloring on one side consistent with being heat induced.There were no signs of bends in the shaft / tube.The outside diameter of the inner shaft shall measure 0.132¿ / +-0.001¿ and the actual measurement on either side of the break was 0.1320¿ which is in specification.The inside reduced diameter of the outer tube shall be 0.1350¿ / +-0.0010¿ and the actual measurement was 0.1340¿ using a pin gage which is in specification (the diameter was measured beyond the a rea where wear may have occurred).There was no allegation of a defect prior to use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the shaft of the high speed blade broke off with no fragments.There was no patient impact.A new blade was used to complete the procedure.

• Brand Name: XPS® BUR - HIGH SPEED ROUND
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7299485
• Report Number: 1045254-2018-00074
• Device Sequence Number: 2116712
• Product Code: EQJ
• UDI-Device Identifier: 00681490692663
• UDI-Public: 00681490692663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/27/2018

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: 08/22/2024
• Device Model Number: 1883262HS
• Device Catalogue Number: 1883262HS
• Device Lot Number: 0211848031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/27/2018
• Patient Sequence Number: 1