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

Model Number	1884016HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the tip of the blade was broken during an ess (endoscopic sinus surgery) procedure.It was noted that there was no broken piece(s) of the device that was left inside the patient's body.It was the initial use of the device.There was no delay in the procedure as a result of this event.The procedure was completed using a back-up device.There was no patient impact or injury.
Additional Manufacturer Narrative
Analysis found that there was no portion of the tip that was detached or missing.The inner spiral wrap broke at its proximal most end.The inner spiral wrap break would have been contained by the outer tube while in the handpiece, if a portion detached and became a device fragment, it would have had to occur after the blade was removed from the handpiece.When viewed under magnification, there was damage to the hubs that is consistent with improper or difficulty loading the device 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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis found that the tip was stretched out of the outer tube support area by 0.19¿ which would have resulted in the reported event.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: 9104276
• Report Number: 1045254-2019-00468
• Device Sequence Number: 2113107
• Product Code: EQJ
• UDI-Device Identifier: 20885074080646
• UDI-Public: 20885074080646
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2019

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 Expiration Date: 01/24/2022
• Device Model Number: 1884016HR
• Device Catalogue Number: 1884016HR
• Device Lot Number: 0214793434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/03/2019; 10/03/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/04/2019; 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1