MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. QUADCUT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	1884380EM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During navigated sinus surgery a medtronic navigated quadcut microdebrider blade stopped functioning.The blade was not in direct patient use when the blade was found to be not working.The hub assembly just prior to the blade separated.

• Brand Name: QUADCUT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 950 flanders rd; mystic CT 06355
• MDR Report Key: 18190754
• Report Number: 18190754
• Device Sequence Number: 6466596
• Product Code: HAW
• UDI-Device Identifier: 00763000579272
• UDI-Public: (01)00763000579272(17)251004(10)0227493853
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2023
• Report Date (Section F): 11/20/2023

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: 1884380EM
• Device Lot Number: 0227493853
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 113 KG
• Date Report Sent to FDA: 11/20/2023