MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.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 customer reported that a blade broke during use.There was no patient impact or injury.There customer also reported that two similar events occurred previously.Case 1 of 3 was filed under regulatory report # 3004209178-2017-20317 (medtronic internal reference number 702059037).Case 2 of 3 was filed under regulatory report # 3004209178-2017-20318 (medtronic internal reference number (b)(4)).This regulatory report is being filed for case 3 of 3 (medtronic internal reference number (b)(4)).
Additional Manufacturer Narrative
The product analysis indicates one opened and three sealed samples of part number 1884002 from lot number hg1r6bq were received.Only the opened sample was analyzed.A microscope and calipers were used to evaluate the opened sample.Visually, the inner tip was broken off at the first proximal tooth valley which would have resulted in the reported event.The portion that broke off was not returned however it would have measured approximately ¼¿.The mouth opening where the cutting action is performed showed impact marks on the outer cutter consistent with the damage occurring while the blade was moving in a clockwise direction.There were no signs of misuse or mishandling.Visually, there were no signs of bends in the inner or outer assemblies.There was uneven wear inside the cutting tip which may indicate an interference fit (profile deviation) between the inner and outer assemblies.There was even wear 5/8¿ from the distal face of the inner hub.The inner cutter and outer tube are supplier manufactured.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6945839
• Report Number: 3004209178-2017-21727
• Device Sequence Number: 19012451
• Product Code: EQJ
• UDI-Device Identifier: 20681490047443
• UDI-Public: 20681490047443
• 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,Followup
• Report Date (Section B): 02/23/2018

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: 03/21/2025
• Device Model Number: 1884002
• Device Catalogue Number: 1884002
• Device Lot Number: HG1R6BQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 02/23/2018
• Patient Sequence Number: 1