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

Model Number 1884006HR

Device Problem Material Separation (1562)

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

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare provider (hcp) reported that a blade snapped during use and was asking for a replacement.During the procedure.There was no known patient impact reported.

Manufacturer Narrative

Product analysis: the middle tube spiral wrap was deformed, and both the inner and middle spiral wraps were stretched pushing to tip out of the outer tube support area by 0.27¿ which would have resulted in the reported event.No components became separated from the remainder of the assembly, there were no fragments.A review of the global complaint data showed no other complaints for this lot number.There was no allegation of a defect prior to use.The information most likely indicates aggressive use or improper speed / direction caused the inner spirals wraps to become stretched.The maximum recommended speed is 7,500 rpm in oscillate mode.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: 9179234
• MDR Text Key: 162899866
• Report Number: 1045254-2019-00506
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074080581
• UDI-Public: 00885074080581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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 Expiration Date: 04/09/2023
• Device Model Number: 1884006HR
• Device Catalogue Number: 1884006HR
• Device Lot Number: 0217490094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• 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
• Patient Age: 24 YR
• Patient Weight: 45