N
Patient 1
THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE SHOWS THE DEVICE WAS RETURNED WITH EVIDENCE OF CLINICAL USE. THE CANNULA SHOWED DAMAGE TO THE SHAFT WHICH WAS BROKEN OFF NEAR THE CANNULA HUB. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. DEVICES ARE REJECTED FOR ANY CANNULA SHAFT DAMAGE, THEREFORE THE DEVICE WAS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE. THE MOST LIKELY ROOT CAUSE IS EXCESSIVE FORCE APPLIED, CONTACT WITH A HARD OBJECT, OR SHIPPING/HANDLING DAMAGE. THE INSTRUCTIONS FOR USE (IFU) STATE: - THESE INSTRUMENTS ARE ONLY INTENDED FOR USE BY INDIVIDUALS WITH ADEQUATE TRAINING AND FAMILIARITY WITH MINIMALLY INVASIVE TECHNIQUES. - PRIOR TO USE, READ AND FOLLOW THE INSTRUCTIONS OF THIS INSERT (IFU) AS WELL AS THOSE OF THE INSTRUMENTS TO BE USED DURING THE PROCEDURE. DAMAGE TO THE INSTRUMENT CAN LEAD TO PATIENT INJURIES. ALWAYS INSPECT INSTRUMENT CAREFULLY FOR OVERALL INTEGRITY BEFORE USE. - DO NOT USE EXCESSIVE FORCE. - CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE. - INSPECT THE INSTRUMENT AND PACKAGE BEFORE OPENING. THE CONTENTS OF THE PACKAGE ARE STERILE IF THE PACKAGING HAS NOT BEEN COMPROMISED. IF THE PACKAGE IS DAMAGED OR IF II WAS OPENED AND THE INSTRUMENT WAS NOT USED, RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS FOR RESTERILIZATION BY ETHYLENE OXIDE (ETO) GAS. - INSPECT THE INSTRUMENTS FOR ANY DAMAGE. DO NOT USE THE INSTRUMENT IF ANY DAMAGE IS NOTED. RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.