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

Model Number	1884002
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis results: visually, the distal tip had broken off the inner cutter which would have resulted in the reported event.The portion that became detached measured approximately 0.24¿ in length.The break occurred at the first proximal tooth valley and proceeded to the second proximal tooth valley.The inner assembly was deformed in such a way that indicates the inner blade teeth impacted the outer cutting surface while moving in a cw and ccw direction which resulted in the observed break.The impacts were at the first and third proximal valleys.There were biological contaminants compacted inside the inner assembly.There was a wear mark around the entire outside diameter of the inner shaft 0.57¿ from the distal face of the inner hub.There was no allegation of a defect prior to use.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.Complaint substantiated / confirmed: yes conclusion: 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
A manufacturer representative reported that the tip of the blade broke in the beginning of the surgery.It was confirmed there was no fragment in the operation area.The doctor used another new blade to complete the surgery and there was a delay of about 3 minutes.It was the initial use of the blade.The procedure was a uvulopalatopharyngoplasty.No patient symptoms or complications were associated with the event.

• 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: 7661089
• Report Number: 3004209178-2018-14994
• Device Sequence Number: 14110822
• Product Code: EQJ
• UDI-Device Identifier: 20681490047443
• UDI-Public: 20681490047443
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 06/14/2025
• Device Model Number: 1884002
• Device Catalogue Number: 1884002
• Device Lot Number: HG1WDG1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1