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

Model Number 1883519HR

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2019

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 professional (hcp) reported that the blade was broken/damaged on normal use during the endoscopic sinus surgery.There were no broken pieces remain inside the patient's body.The product was used for the first time and the procedure was completed with a back up product.There was no intervention planned or performed.There was no delay with the procedure.There was no patient impact.

Manufacturer Narrative

Analysis found that there was a residue consistent with biological contaminants on the device.The inner assembly pulled out freely and visually, the spiral wrap broke at the proximal end that would have resulted in the reported event.The break point showed the spiral wrap was twisted in on itself in a clockwise direction which is consistent with excess torsional load.The inner tip moved freely therefore it was not the source of the torsional load.The middle assembly spun freely by hand.The distal side of the locking area on the rotating hub was deformed in such a way that indicates bending or prying the blade while in the handpiece.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
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9400358
• MDR Text Key: 168910874
• Report Number: 1045254-2019-00646
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074080659
• UDI-Public: 00885074080659
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

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: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: HG39XE6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• 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