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

Model Number 1882040HR

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis found that there were only trace amounts of a residue consistent with biological contaminants on the device.The tip was present and in good condition.There were no bends or concentricity issues.There were no loose components.There was deformation of the front hub.Functionally, the blade loaded into a handpiece ran at 3,000 rpm in oscillate mode, and cut saw bone with no issues.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 the tip of the blade broke during an endoscopic sinus surgery procedure.The hcp noted that the inner cylinder of the blade was broken, not the external cylinder.There were no broken pieces remained in the patient's body.There was no intervention planned or performed as a result of this event.There was 10 minutes procedure delay.The procedure was completed with a back up device.There was no patient impact or injury.

• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8181301
• MDR Text Key: 130981650
• Report Number: 1045254-2018-00722
• Device Sequence Number: 1
• Product Code: EQJ
• 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
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1882040HR
• Device Catalogue Number: 1882040HR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/19/2018
• 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