SEGWAY ENDOSCOPIC SYSTEM

Additional Manufacturer Narrative

THE SEGWAY RETROGRADE LIGAMENT KNIFE BLADE BROKE RIGHT AT THE BLADE JUNCTION. THE BLADE WAS USED IN A SURGICAL PROCEDURE FOR PLANTAR FASCIOTOMY. THE MEDICAL FACILITY DID NOT RELEASE THE DEVICE FOR EVAL UNTIL MONTHS LATER. THE BROKEN PIECE OF THE DEVICE WAS RETRIEVED AND A NEW DEVICE FROM THE SAME LOT NUMBER 1061401 WAS USED TO COMPARE AND MAKE SURE ALL PIECES WERE RECEIVED. THE SURGEON REPORTED THAT THE PT WHO IS THE SUBJECT OF THIS REPORT HAD EXTREMELY HARD FASCIA. THE BROKEN BLADE HAS BEEN INSPECTED. TEST BLADES WERE ALSO INSPECTED. CONCLUSION TO INCIDENT: SINCE NO OTHER INCIDENTS HAVE BEEN REPORTED AND NO DEFORMITIES WERE VISIBLE TO THE BLADE IT, HAS BEEN CONCLUDED THAT THIS WAS AN ISOLATED INCIDENT AND WAS LIKELY DUE TO THE BLADE ERRONEOUSLY BEING PRESSED UP AGAINST THE CALCANEUS WITH FORCE. THE RISK FILES WERE ALSO REVIEWED AND UPDATED ACCORDINGLY TO CONSIDER AND MITIGATE THIS RISK.

Description of Event or Problem

THIS REPORT IS A FOLLOW UP TO A REPORT SUBMITTED BY (B)(6) ON 06/17/2014. WHILE USING THE SEGWAY RETROGRADE LIGAMENT KNIFE, THE TIP OF THE BLADE BROKE OFF INSIDE THE GUIDE WHICH WAS IN THE PTS FOOT. USING A SCOPE AND FLUOROSCOPY, IT WAS DETERMINED THAT THE PIECE WAS RETRIEVED FROM THE PT'S FOOT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? RIGHT FOOT PLANTAR FASCIOTOMY . DEVICE USAGE PROBLEM: DEVICE FAILED. (E.G. BROKE, COULDN'T GET IT WORK OR STOPPED WORKING).