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

Model Number 1883519HR

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

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 a manufacturer representative that during the procedure, the blade started to shake and the surgeon realized that the rotate tip stopped functioning correctly, it was unable to remove the tissue.The inner and outer blade were stuck together and the cutting chamber was not open.It was noted that there were no broken pieces left inside the patient's body.There was no intervention planned or performed as a result of this event.There was a 15-minute delay with the procedure and the procedure was completed with a back-up device.There was no patient impact or injury.

Manufacturer Narrative

Analysis found that functionally, the inner assembly would spin, and the middle assembly would index freely by hand which is not consistent with the reported event.The blade was loaded into a handpiece, ran at the maximum recommended speed of 3,000 rpm in oscillate mode and it was observed that the middle assembly would rotate back and forth with the inner assembly by approximately 5 to 10 degrees.The observed motion of the middle assembly is an indication that the spiral wrap sustained excess torsional loads which affected the rigidity of the spiral wrap; it is interpreted that this is what is meant by the reported ¿shake¿.Torsional loads are not applied to the device during production.Although there is no specification for the rigidity of the spiral wrap, the customer would have likely experienced a reduction in cutting performance.There are checks for damage to the device during manufacturing and there was no allegation of a defect prior to use.Additional information suggest that fdm 4114, fdr 3221 and fdc 67 no longer applies 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: 8671483
• MDR Text Key: 147184646
• Report Number: 1045254-2019-00281
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074080659
• UDI-Public: 00885074080659
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: HG2PXRL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 76