PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT A PRECICE NAIL WAS IMPLANTED IN (B)(6) ON A STATURE PATIENT. HIS RIGHT SIDE LENGTHENED BUT THE LEFT NAIL DID NOT. THE PATIENT LOST FAITH IN HIS ORIGINAL SURGEON, SO HE CAME TO (B)(6) TO HAVE DR. (B)(6) SWAP OUT THE NAIL. THE NAIL DID WORK ON THE BACK TABLE WITH A FAST DISTRACTOR, BUT (B)(6) STILL WANTED US TO SWAP IT.

Additional Manufacturer Narrative

THE INVESTIGATION REVEALED A COMPLAINT REPORTING THAT A PRECICE NAIL DID NOT WORK POST IMPLANTATION. THE NAIL INVOLVED IN THE EVENT WAS RECEIVED BY MANUFACTURER FOR INVESTIGATION. THE NAIL WAS REMOVED AND TESTED WHERE IT WAS ABLE TO DISTRACT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SPECIFIED REGULATORY REPORTING HAS BEEN COMPLETED. A REVIEW OF DEVICE HISTORY RECORD FOR THE NAIL CONFIRMED NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THAT THE FINISHED PRODUCT MET ALL REQUIRED QUALITY INSPECTIONS. THE NAIL WAS TESTED ACCORDING TO PRODUCTION STANDARDS WHERE IT WAS ABLE TO PASS ALL ACCEPTANCE CRITERIA, INDICATING THAT THE NAIL IS FULLY FUNCTIONING. COMPLAINT MONITORING WILL CONTINUE AND ADDITIONAL ACTION WILL BE TAKEN IN THE EVENT THAT AN ADVERSE TREND IS IDENTIFIED. NO ADDITIONAL ACTION IS PLANNED AT THIS TIME.