MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MICRODEBRIDER BLADES AND BURS; BUR, EAR, NOSE AND THROAT

Model Number XOM UNK MICDEBBUR

Device Problem Material Integrity Problem (2978)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis confirmed the reported event and noted that a part of a broke bur was stuck inside the device; seals and bearing were worn and replaced of the handpiece.Visually, the inner shaft and hub bushing were dislodged and missing from the inner hub when returned and there was deformation in the hub: the chevrons on the proximal end of the hub were flared outward and the distal end of the hub was malformed.The outside diameter of the inner hub shall be 0.330 ± 0.002 inches and measured 0.329 inches in the undamaged area and up to 0.343 inches in the deformed area which was out of specification.Functional testing could not be performed due to the broken state of the device.Conclusion was in the returned condition, 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

Healthcare professional reported that the device was not working properly.There was no patient involvement.

Manufacturer Narrative

Product analysis #(b)(4), (b)(6) 2023, dpp, quality technician: complainant: (b)(6) hospital product receipt/condition: 1 opened sample, part and lot numbers [no information].Although there was initially no information on the part number, the device configuration was consistent with being a part of the microdebrider high-speed bur product family.Only the inner hub was returned.Reported failure summary: it was reported that the device was not working properly.There was no patient involvement.Methodology / results: the service report (b)(4) confirmed the reported event and noted that a part of a broke bur was stuck inside the device; seals and bearing were worn and replaced.Visually, the inner shaft and hub bushing were dislodged and missing from the inner hub when returned and there was deformation in the hub: the chevrons on the proximal end of the hub were flared outward and the distal end of the hub was malformed.The outside diameter of the inner hub shall be 0.330 ± 0.002 inches and measured 0.329 inches in the undamaged area and up to 0.343 inches in the deformed area which was out of specification.Functional testing could not be performed due to the broken state of the device.Documents used: inner hub drawing (b)(6) revision t.Equipment used: microscope and calipers (5660-j).¿ complaint substantiated / confirmed: yes.Conclusion: in the returned condition, there was an out of specification condition that was related to the complaint (due to physi cal 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

Hcp reported that the device was not working properly.There was no patient involvement.On follow up it was reported that bur was broken while removing from handpiece.No fragments/pieces detach from the broken device.

• Brand Name: MICRODEBRIDER BLADES AND BURS
• 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: 16792777
• MDR Text Key: 313810163
• Report Number: 1045254-2023-00327
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

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: XOM UNK MICDEBBUR
• Device Catalogue Number: XOM UNK MICDEBBUR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/23/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 08/14/2023
• 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