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

Model Number	1884006EM
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
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 manufacturer representative that the inner blade fell off during the procedure.The device was used in an osculating manner.It was the first time the blade was used.The case was completed using a different blade.There was a delay in the procedure.There was no patient impact.
Additional Manufacturer Narrative
Analyis found that there was a residue consistent with biological contaminants on the device.Visually, the middle assembly spiral wrap was stretched, and the tip was pulled away from the assembly.There was no detachment of any component.There was uneven wear on the inside diameter of the middle assembly cutting tip.The distal teeth of the middle assembly were deformed.The front hub locking area was deformed as well.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received stated that the blade was disconnected from the handpiece and it resulted to broken fragments from the device.There were no fragments left inside the patient's body.

• 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: 8119292
• Report Number: 1045254-2018-00669
• Device Sequence Number: 11180120
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: 04/23/2020
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0215391710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1