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

Model Number	1882940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visually, portions of the distal inner tip were broken off and would have resulted in the reported event.A fragment that broke off and was returned measured approximately 0.093 inches wide and 0.027 inches in length.There were biological contaminants on the inside diameters of the inner and outer tips.Under magnification, when the inner assembly was removed for additional analysis, striations were observed on the proximal end of the inner shaft.Functionally, the inner assembly spun freely by hand with no binding.The inner and outer hub seals were in place and in good condition.However, 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 no out of specification condition that was related to the complaint (due to physical damage).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
The distributor reported that during septoplasty procedure, when the doctor used the blade about 10 minutes, he found there was a metal filings at the tip of the blade.To prevent the harm to the patient, the doctor changed a new blade to complete the surgery.No patient impact.No intervention planned or performed.The surgery was delayed for 5 minutes.The back up device was used to complete the surgery.On follow-up, it was reported that the metal fillings were not noticed before using the device and not sure that was a degraded part of the blade.

• 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 15124723
• Report Number: 1045254-2022-00439
• Device Sequence Number: 15270838
• Product Code: EQJ
• UDI-Device Identifier: 00763000532857
• UDI-Public: 00763000532857
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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 Model Number: 1882940
• Device Catalogue Number: 1882940
• Device Lot Number: 0223438421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/28/2022
• Date Device Manufactured: 12/04/2021
• 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: Female