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

Model Number	1882040
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A health care provider (hcp) reported via distributor that at the beginning of the functional endoscopic sinus surgery, he noticed that the blade vibrated excessively.The surgeon tried reinstalling the blade however the problem still persisted.As a result, the doctor used a new blade to complete the operation.The second blade functioned properly without vibration using the same handpiece.There was a procedure delay of 3 minutes.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that the inner blade would spin freely by hand.There was no damage to the tip.Visually, the inner shaft was bent just distal to the inner hub which would have resulted in the reported event.When viewed under magnification, there was damage to the hubs that is consistent with improper of difficulty loading the blade into the handpiece: dimples on the front hub prior to the locking area caused by a misalignment of the handpiece locking mechanism; locking area deformation caused by the back side of the front collet of the handpiece; and deformation of the proximal inner hub chevrons caused by the handpiece drive mechanism.Shear or bending forces while loading may bend the shaft.There were no loose components.Even with the deformation of the hubs, functionally, the device loaded securely into a handpiece, ran at 3,000 rpm in oscillate mode/direction, and vibrated as reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8517857
• Report Number: 1045254-2019-00189
• Device Sequence Number: 19292607
• Product Code: EQJ
• UDI-Device Identifier: 00681490613286
• UDI-Public: 00681490613286
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1882040
• Device Catalogue Number: 1882040
• Device Lot Number: 0215460291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1