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

Model Number	1884012EM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during fess surgery, connection from the blade is broken near the hub.There was no intervention performed / planned.No broken pieces of the reported product remain inside the patient's body.There was no delay in procedure.The procedure was completed with backup product(s).
Additional Manufacturer Narrative
H3 : analysis of part number 1884012em of lot number 0222708678 found that there was a residue consistent with biological contaminants on the device.Portions of the tracker wire were cut.Visually, the inner shaft broke 0.57 inches from the distal end of the inner hub which would have resulted in the reported event.There were striations around the outside diameter of the break point.Under magnification, there were indentations on the rotating hub.Functional testing could not be performed due to the broken state of the device.There was no allegation of a defect prior to use.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 : previous fdm b21, fdr c21, fdc d16 and img g04041 codes no longer apply.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up it was reported that the blade broken while attempting to remove the blade from the handpiece to clear the blockage.Fragment detached only when the shaver blade has been removed from the handpiece to clean the blade and broken parts contained in the handpiece or in the outer blade that prevented the fragments from contacting the patient.There has been no patient impact, but the operation took longer since a new shaver blade had to be obtained and connected.

• Brand Name: XPS® SYSTEM NAVIGATED 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 13504806
• Report Number: 1045254-2022-00056
• Device Sequence Number: 12100832
• Product Code: EQJ
• UDI-Device Identifier: 00613994617415
• UDI-Public: 00613994617415
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K050438
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 07/25/2023
• Device Model Number: 1884012EM
• Device Catalogue Number: 1884012EM
• Device Lot Number: 0222708678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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 Sex: Unknown