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	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 1884012em from lot number 0213063055 was received.A microscope and calipers were used to evaluate the device.Visually, the tip of the middle tube had become detached at the distal end of the spiral wrap which would have resulted in the reported event.The portion that became detached was not returned.An additional detached portion of spiral wrap was included which measured approximately 0.4¿ long.A note on the finish goods box indicated ¿malfunctioned during case¿.There was no damage to the inner assembly teeth.There was a residue consistent with tape adhesive at the distal end of the outer tube which may or may not have been a contributing factor in the reported event.There were no signs of excess pressure used or improper loading of the blade.The ifu indicates the tools are available for resection of soft tissue and bone for surgical procedures; insertion of metal objects in accessory tip may cause the accessory; bending or prying may break the accessory; do not use excessive force to pry or push bone with the attachment, tool or blade during dissection.The reported issue was confirmed.The device condition was out of specification as it relates to the complaint.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 an issue with a rad12 tracking blade.It appeared that the blade's spiral wrap was damaged.Additional information received indicates the spiral wrap extension did not result in fragments.However, the product analysis indicates the tip of the spiral wrap was detached.There was no reported patient impact or 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: 6761737
• Report Number: 1045254-2017-00262
• Device Sequence Number: 964760
• Product Code: HAW
• UDI-Device Identifier: 00613994617415
• UDI-Public: 00613994617415
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 07/10/2017

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: 03/20/2019
• Device Model Number: 1884012EM
• Device Catalogue Number: 1884012EM
• Device Lot Number: 0213063055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1