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

Model Number	1884005HRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened sample, part number 1884005hre, from lot number [no information] was received.Evaluation found that the distal tip had broken off the inner cutter which would have resulted in the reported event.The portion that became detached measured approximately 0.23¿ in length.The break occurred at the first proximal tooth valley.The outer assembly was deformed in such a way that indicates the inner blade teeth impacted the outer teeth while moving in a cw and ccw direction which resulted in the observed break.There was substantial uneven wear at the cutting tip which indicates deformation of the tip had to be present in order for this failure to occur.There was minor wear around the circumference of the inner shaft 0.57¿ from the distal face of the inner hub.When viewed under magnification, there was damage to the hubs that is consistent with improper loading: dimples on the front hub prior to the locking area caused by the handpiece locking mechanism; and locking area deformation caused by the back side of the front collet of the handpiece.The information more likely indicates a use issue resulting in erratic compression and torsional loads.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.
Event or Problem Description
During use, the tip of the inner shaft was broken.There were no fragments.There was no patient impact or injury, the procedure was completed with back-up product.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7604882
• Report Number: 1045254-2018-00248
• Device Sequence Number: 16492930
• Product Code: EQJ
• UDI-Device Identifier: 00885074080567
• UDI-Public: 00885074080567
• 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): 06/15/2018

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 Model Number: 1884005HRE
• Device Catalogue Number: 1884005HRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1