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

Model Number 1883274HSE

Device Problem Material Separation (1562)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis visually, the inner shaft was bent until broken 0.61 inches from the distal end of the inner hub.There was deformation on the outside diameter of the inner hub.The outside diameter of the inner hub should be 0.330 ± 0.002 inches and measured 0.328 inches in the undamaged area and 0.354 inches in the deformed area which was out of specification and would have resulted in the reported event.The inner hub seal was worn and dislodged.The chevrons on the proximal end of the inner hub were worn and had indentations.A portion of the outer hub was returned and broken.Functional testing could not be performed due to the broken state of the device and missing portions of the assembly.If information is provided in the future, a supplemental report will be issued.

Event Description

Analysis found a piece of a broken bur is stuck in the collet.

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

Information was received from hcp.No product allegation information provided.No patient impact.On follow up it was mentioned that the device has been repaired because the bur was blocked into m5 and no fragments remained in patient body.There was no patient impact.

• Brand Name: XPS® BUR - DIAMOND
• 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: 13477526
• MDR Text Key: 286012881
• Report Number: 1045254-2022-00047
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/12/2022

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: 1883274HSE
• Device Catalogue Number: 1883274HSE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 04/11/2022
• 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