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

Model Number 1882916

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis found, visually, there was no damage in the construction of the device.There was no damage to the distal tip and no loose components.However, there was contamination within the inside diameter of the inner cutter tip.The proximal outside diameter of the outer hub (locking area) shall be 0.340 +0.003/-0.001 inches and the actual measurements were between 0.339 and 0.340 inches which was in specification.Functionally, the inner assembly spun freely by hand with no binding.The blade fit securely into a handpiece and oscillated at 1500rpm with no issues.In the returned condition, there was no out of specification condition that was related to the complaint.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 Description

It was reported that during normal functional endoscopic sinus surgery, the blade started grinding noise when engaged.Basically, when the surgeon stepped on the foot pedal, the entire blade would rotate on the microdebrider handpiece.For example, the rad 60 was bent up at the 12 o¿clock position when he stepped on the foot pedal it rotated from 12 to 3 o¿clock position until he stepped off the front pedal.That was when the handpiece was unlocked.When the handpiece was locked, the distal end of the blade would vibrate significantly.The procedure was completed with backup product.There was a procedural delay of less than 1 hour.There are no patient implications or affects.

Manufacturer Narrative

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 Description

Additional information received, when the blade was discovered to be vibrating they stopped using it on the patient.The device was not checked for wobble prior to use.

• Brand Name: XPS® BLADE
• Type of Device: 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: 18213879
• MDR Text Key: 330245714
• Report Number: 1045254-2023-01013
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00721902755057
• UDI-Public: 00721902755057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 1882916
• Device Catalogue Number: 1882916
• Device Lot Number: 0227085386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 91 KG