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

Model Number	1884006EM
Medical Device Problem Codes	Difficult to Insert (1316); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
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 scrub nurse wanted to change the blade during the procedure, but they found that the new blade was unable to be attached to the handpiece.Upon closer inspection, the hcp realized that the blade was broken at the bottom.There was no patient impact.
Additional Manufacturer Narrative
Analysis of the blade found that the inner shaft broke 0.53¿ from the distal face of the inner hub.There were striations around the outside diameter of the break point.The break point corresponds to the proximal end of the outer tube in the front hub.There was no damage to the distal tip.When viewed under magnification, there was deformation and indentations of the front hub locking area.There were no bends or signs of a concentricity issues.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information receive from health care provider (hcp) reported via manufacturer representative mentioned that the blade was used for fess+igs.There was no delay in the case.The case was completed as the blade was no longer required, and the blade hub was removed easily from the handpiece.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7730503
• Report Number: 1045254-2018-00332
• Device Sequence Number: 2771660
• Product Code: HAW
• UDI-Device Identifier: 00613994617408
• UDI-Public: 00613994617408
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 03/27/2020
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0215223666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 08/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/10/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1