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

Model Number	1884012HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the blade broke while the surgeon started using it.There was no patient impact or injury.
Additional Manufacturer Narrative
Product receipt / condition: 1 opened sample, part number 1884012hr, from lot number hg1s7at.Visually, the middle tube tip broke off at the spiral wrap which would have resulted in the reported event.The portion that became detached measured 0.59¿ long.When viewed under magnification, there was deformation of the locking area on the front hub consistent with aggressive use.The 2nd proximal tooth was bent outward which is an indication of contact with an inappropriate material and/or aggressive use.There was no allegation of a defect prior to use.The information indicates excess pressure was applied during use which caused the deformation of the locking area and damage to the tip.Complaint substantiated.There was an out of specification condition identified as it relates to the complaint.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: 7308083
• Report Number: 3004209178-2018-04284
• Device Sequence Number: 1090845
• Product Code: EQJ
• UDI-Device Identifier: 20885074080608
• UDI-Public: 20885074080608
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 04/05/2021
• Device Model Number: 1884012HR
• Device Catalogue Number: 1884012HR
• Device Lot Number: HG1S7AT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1