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

Model Number	1884380EM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the case, all the blades broke in the same place more towards the shaft.The broken part remained in the m4 handpiece.There was no known patient impact.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Correction: b3: the event date has been updated.B5: the event description has been updated.D4: expiration date, lot number and unique identifier (udi) has been updated.Additional codes: previously applied code imf f24 is no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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.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
Additional information received stated that the broken part remained in the m4 handpiece until taken out.Fragments did not fall into patient.There was a procedural delay of thirty minutes.The blade was run at a speed of 5000 rpm.There was no patient impact.
Event or Problem Description
Product analysis found that the blade was not broken in two or more pieces.Therefore, this did not and does not meet the reporting requirements.
Additional Manufacturer Narrative
H3: visually, there was contamination on the outside diameters of the outer tube tracking hub.There were striations 0.36 inches from the distal end of the inner hub on the outside diameter of the inner shaft and striations on the outside diameter of the inner cutter tip when returned.Additionally, there was a white residue consistent with adhesive on the outside diameter of the inner shaft.Per the drawing, a thin layer of loctite is applied between the retainer and rotating hub.For further analysis, the outside diameter of the inner cutter tip shall be 0.145 ± 0.001 inches and the actual measurement was 0.145 inches which was in specification.Functionally, the inner and middle assemblies were initially seized together, but after unseizing with excessive force, binding was observed while indexing the inner assembly by hand.Console functional testing was not performed due to the aforementioned defects.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.Device evaluation received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.H6: previously applied codes fdm b17, fdr c20 and fdc d14 are no longer applicable.Additional codes: previously applied code img g04041 codes is no longer 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.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.

• 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: 19057319
• Report Number: 1045254-2024-00498
• Device Sequence Number: 5870440
• Product Code: EQJ
• UDI-Device Identifier: 00763000579272
• UDI-Public: 00763000579272
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

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 Expiration Date: 12/03/2025
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0227880462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/08/2024; 05/21/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/03/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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 Sex: Unknown