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

Model Number	1884012EM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened sample, part number 1884012em, from lot number 0212765628 was received.There was a residue consistent with biological contaminants on 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 measured 0.48¿ long.As indicated by the customer, the damage occurred during use with no allegation of damage prior to use.There was damage to the inner and middle assembly teeth which may be an indication of contact with an inappropriate material or aggressive use.The ifu (instructions for use) 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 to break leaving fragments in the wound; 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.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
It was reported that the tip of the blade broke into the patient.The surgeon easily retrieved the broken tip from the patient, no medical intervention was required.The procedure was completed with another bur.There was no patient impact.
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: 6526791
• Report Number: 1045254-2017-00124
• Device Sequence Number: 13867761
• 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,Followup
• Report Date (Section B): 04/03/2017

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: 01/30/2019
• Device Model Number: 1884012EM
• Device Catalogue Number: 1884012EM
• Device Lot Number: 0212765628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78