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

Model Number 1882569HS

Device Problem Material Fragmentation (1261)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that intra-op of ess procedure, the bur could not be removed anymore.The tip of the bur was partially broken.There was a procedure delay of 20 minutes.There was no intervention planned/performed.The procedure was completed with the used of backup product(s).There was no patient impact.On follow up it was mentioned that the tip of the bur broken while being used on a patient.The broken bur was contained in the handpiece mostly, but the detached tip fell on the patient.The fragment was removed from the patient with forceps and did not remain in the patient.No other fragments remained in the patient.

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.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.

Manufacturer Narrative

H3: the service report confirmed the complaint and removed the bur and disassembled and cleaned the device; the bearing and other parts were replaced; a final operation inspection was performed and it was confirmed that there were no abnormalities (with the handpiece).Visually, the inner shaft was returned bent until broken approximately 0.48 inches from the distal end of the inner hub.The distal diamond grit tip was lodged inside the outer tube and was compacted with contaminant.There was deformation in the distal outside diameter of the inner hub which would have resulted in the reported event.The outside diameter of the inner hub should be 0.330 ± 0.002 inches and measured 0.330 inches in the undamaged area and up to 0.362 inches in the deformed area which was out of specification.There were striations on the inner shaft proximal to outer hub.The hub bushings were rough and worn.The inner hub seal was in place but was worn.Functional testing could not be performed due to the broken state of the device.There was an 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 Description

On follow-up, the device was used in forward mode with default speed setting.The device was used correctly as per ifu.

• 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: 15054582
• MDR Text Key: 301922491
• Report Number: 1045254-2022-00413
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 1882569HS
• Device Catalogue Number: 1882569HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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