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

Model Number	1884380HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during functional endoscopic sinus surgery, quadcut blade broke into two pieces.Procedure was completed with another quadcut blade.There was no patient impact.
Additional Manufacturer Narrative
H3: product analysis found that visually, there were no traces of contamination found on the returned device.The device was in a broken condition when returned.There was no damage noted on the outer tube, outer, rotating, and inner hubs.However, the inner shaft was broken and measured 0.602 inches from the distal end of the inner hub to the broken point.There were traces of striations noted at the broken point of the shaft.The remaining portion (distal end) of the inner shaft was stuck inside the outer assembly.Functional testing could not be performed due to the broken state of the device.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).H6: previosuly applied fdm-b21 fdr-c21 fdc-d16 and img g04041 codes are not applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 19496581
• Report Number: 1045254-2024-00873
• Device Sequence Number: 6812496
• Product Code: EQJ
• UDI-Device Identifier: 00613994779182
• UDI-Public: 00613994779182
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 1884380HR
• Device Catalogue Number: 1884380HR
• Device Lot Number: 0227052002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male