MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS SYSTEM NAVIGATED BLADE; INSTRUMENT, STEREOTAXIC

Model Number	1884006EM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
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
It was reported via health care professional that during functional endoscopic sinus surgery, the blade's tip broke into a small piece.There was no broken piece of the reported product remain inside the patient's body.The procedure was completed with backup product(s) with no delay.There was no intervention performed/planned there was no patient impact.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10381593
• Report Number: 1045254-2020-00353
• Device Sequence Number: 3145795
• Product Code: HAW
• UDI-Device Identifier: 00613994617408
• UDI-Public: 00613994617408
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0219384206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1