MalfunctionONN
ORTHOSENSOR VERASENSE KNEE SYSTEM
Received Nov 7, 2016 · Event occurred Oct 25, 2016
Report MW5065944 · MDR key 6092304
Device
Generic name
Verasense Knee System For Journey Ii Bcs
Manufacturer
Orthosensor 1855 Griffin RoadCatalog number
SNN-JRNYBCS78-L
Lot number
051315V12704
Product problems
- Computer Software Problem
- Disconnection
Patient
71 YR
- No Information
- No Information
Narrative
Description of Event or Problem
PRODUCT WAS ACTIVATED THEN PROPERLY TRANSFERRED TO STERILE FIELD. DEVICE THEN DISCONNECTED FROM THE RECEIVER, AND NO LONGER TRANSMITTED DATA. THIS WAS DISCOVERED WHILE ATTEMPTING TO ZERO THE DEVICE. ALTHOUGH TROUBLESHOOTING ATTEMPTS WERE MADE, THE DEVICE WAS NEVER AGAIN ABLE TO TRANSMIT DATA, AND SO WAS NOT INSERTED IN THE PATIENT. THE DEVICE WAS RETURNED TO SPONSOR FOR REIMBURSEMENT.