PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY TO RECHARGE THE PRECICE NAIL NEITHER THE FAST DISTRACTOR MAX NOR THE ERC WERE ABLE TO RETRACT THE NAIL DESPITE NUMEROUS ATTEMPTS. THE ERC SHOWED THERE WAS A CONNECTION BETWEEN MAGNETS WITH A GREEN CHECK MARK BUT THERE WAS NO ACTUAL MOVEMENT OF THE NAIL. THE NAIL WAS THEN REMOVED AND TESTED ON THE BACK TABLE WITH NO SUCCESS. THE NAIL HAD BEEN EXTRACTED TO 78 MM PRIOR TO THE RECHARGE SURGERY. POST-OP, THE PATIENT REPORTED THAT DURING HIS FINAL DISTRACTIONS WITH THE ERC VIA THE PRESCRIPTION HE WAS HEARING A CLUNKING SOUND. HIS PRESCRIBED TREATMENT WAS .33 MM X 3 TIMES A DAY.