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

Model Number	1884012EM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device have not been returned.A product analysis has not been performed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the tip of the blade broke during surgery.There was no patient injury.

• 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: 6709466
• Report Number: 1045254-2017-00239
• Device Sequence Number: 1038441
• Product Code: HAW
• UDI-Device Identifier: 00613994617415
• UDI-Public: 00613994617415
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2017

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: 03/26/2019
• Device Model Number: 1884012EM
• Device Catalogue Number: 1884012EM
• Device Lot Number: 0213089023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/12/2017
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 48