MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1882040

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported via distributor that a device broke while on initial stage of the procedure.The mode in the console was in oscillating mode.A new blade was opened to continue the case.There was no patient impact.

Manufacturer Narrative

H3: product analysis found out that visually, the outer tube was bend and the inner shaft was bent which would have resulted in the reported event.The bend corresponds to the distal side of the front hub.The extent of the bend in the outer tube was immediately noticeable upon receipt which likely indicates manufacturing and the user would have noticed this damage ¿if¿ present during manufacturing or before use.The bend was even more apparent when on the handpiece.The inner shaft was broken 1¿ from the distal side of the inner hub which corresponds to the bend in the outer tube and indicates it occurred during rotation.There were striations around the outside diameter of the break point indicating metal on metal contact during use.When viewed under magnification, there was deformation and indentations of the front hub locking area consistent with aggressive use.A review of the xpi did not indicate any evidence to point to improper manufacturing and there are checks for damage throughout the process.There was no allegation of a defect prior to use / placement into the handpiece.The information indicates excess pressure was applied while in the handpiece during rotation which caused the deformation of the locking area and the bend in the outer tube; which then caused the inner shaft and outer tube to rub together until the inner shaft broke.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.There were no signs of heat deformation or discoloring.The ifu warns that excessive pressure applied to a bur/blade may cause a fracture.H6: fdm 4114, fdr 3221, and fdc 67 no longer apply.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9465420
• MDR Text Key: 177377984
• Report Number: 3004209178-2019-23745
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490613286
• UDI-Public: 00681490613286
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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: 1882040
• Device Catalogue Number: 1882040
• Device Lot Number: HG2N6MS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1