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

Model Number	1882940
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were 2 blades of the same lot used in the surgery and were submitting 2 mdrs for the same event blade 1882940 5pk inferior turbinate 2.9 lot 0220850191 this is same event with regulatory report 1045254-2021-00084.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by a health care professional that the inner blade of the product had a metal coating which began to flake off while the product was being used inside the sinus cavity during his 4th case.The blade was removed and replaced with a new blade, which was from the same lot and had the same issue again.Upon follow up it was stated that fragments were noticed in the nasal passage.There was no patient impact.A 2nd back up device from another lot# was used to complete the procedure.There were delays in the procedure.

• 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: 11398591
• Report Number: 1045254-2021-00085
• Device Sequence Number: 3374614
• Product Code: EQJ
• UDI-Device Identifier: 00681490863360
• UDI-Public: 00681490863360
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: 1882940
• Device Catalogue Number: 1882940
• Device Lot Number: 0220850191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1