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

Model Number	1884006EM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
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 professional (hcp) reported via manufacturer representative that the tip of the blade broke off during the procedure.There were no fragments that fell on the patient.There was no delay in the procedure as another device was used.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that visually, the middle assembly cutting tip was stretched out of its seated position which would have resulted in the reported event.No portion of the device became detached.The inner assembly would spin with some resistance.The middle assembly was rotated by the hub and the tip would not turn which indicates a broken internal spiral wrap.The distal inside diameter of the middle assembly was worn unevenly and the locking area of the rotating hub was deformed in such a way that indicates aggressive use.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: 8436537
• Report Number: 1045254-2019-00145
• Device Sequence Number: 277865
• Product Code: HAW
• UDI-Device Identifier: 00613994617408
• UDI-Public: 00613994617408
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• 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): 05/08/2019

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: 11/05/2020
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0216627116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 52