MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Field systems engineer visited the site to further look into the reported event.He discovered that the inaccuracy happened when the surgeon moved the reference frame.He then explained to the site that the reference frame should not be moved in order to maintain accuracy.No further issues were reported.A subsequent full system check-out was completed (not specific to this case) and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that while in a spinal fusion procedure, the surgeon placed screws on the patient's left and they were all placed correctly.She moved to the patient's right side and could not get the retractor in, so she took the perc pin frame off of the pin and put in the retractor.She put the frame back on and the retractor was pushing on the pin.She checked accuracy and was off.She tried to reposition the frame but was still inaccurate.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

Correction to unique device identifier (udi) now provided.A software investigation was completed and found accuracy will be lost if the reference frame is moved, software is functioning as designed.The instructions for use (ifu) which accompanies this device contains the following warnings regarding frame movement: "warning: make sure that the reference frame assembly is rigidly attached and locked (tightened) with respect to the relevant anatomy.If the post or clamp moves in relation to the anatomy, navigational inaccuracy may result." and "warning: do not bump or reposition the reference frame after registration.Such movement may result in inaccurate navigation.If the reference frame moves in relation to the patient anatomy at any time after registration, you must reregister.".

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6195376
• MDR Text Key: 63084818
• Report Number: 1723170-2016-05876
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 105