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

Model Number 1882569HS

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2020

Event Type  malfunction  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported that a bur's tip was broken during an endoscopic sinus surgery, there was no known impact or consequence to patient.The procedure was completed with a back up product with no delay.

Manufacturer Narrative

H3 the product analysis result indicates that the inner assembly tip broke off at the spiral wrap.The portion that became detached measure 0.815¿ with a piece of spiral wrap extending outward.The spiral wrap was twisted in on itself in a clockwise direction indicating unusual torsions load and aggressive use.The distal inside diameter of the outer tube was rough and worn through the outer tube wall which is typical of friction caused by excess pressure during use or excess speed.The adjacent inner assembly was rough and worn.There was no allegation of a defect prior to use.A review of the xpi did not indicate any evidence to point to improper manufacturing and there are checks for damage to the components and assemblies throughout the process.The information indicates excess pressure was applied while in the handpiece during rotation which caused friction and excess torsional loads resulting in the tip breaking off at the spiral wrap.Excessive pressure applied to bur may cause damage; and bending or prying may break the blade or bur.In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage).The most likely underlying cause is consistent with, misuse / use error.H6: additional information suggest that fdm 4118 , fdr 3233 and fdc 11 are no longer applicable to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information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.

• 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
• MDR Report Key: 9706265
• MDR Text Key: 180610896
• Report Number: 1045254-2020-00086
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• 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: 02/04/2020
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR