MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION S8 PLATFORM NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number STEALTHSTATION S8 PREMIUM NAVLOCK

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 05/28/2020

Event Type  malfunction  

Event Description

Navlock navigation attachment jammed on tap while tap was in patient.Tap could not reverse because of navlock contact with mazor robot arm.After trying several options to remove the instrument the physician decided to use a metal cutting burr to cut the faulty instrument off of the tap to allow the tap to be reversed and removed safely from the patient.Towels were laid around surgical site to protect from metal shavings.

• Brand Name: STEALTHSTATION S8 PLATFORM NAVLOCK
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 300 foster street; littleton MA 01460
• MDR Report Key: 10534293
• MDR Text Key: 206964503
• Report Number: 10534293
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/11/2020,05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STEALTHSTATION S8 PREMIUM NAVLOCK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA