Description of Event or Problem · 0
IT WAS REPORTED THAT A CURVED CANNULA WAS RETURNED FOR AN UNKNOWN REASON AND VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS BROKEN. THE J- STYLET WAS TESTED WITH A KNOWN GOOD CURVED CANNULA AND INTRODUCER CANNULA AND REVEALED THAT IT LACKS ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, THE IFU STATES THAT AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION MUST BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENTS OR PROBE. EXCESSIVE FORCE CAN RESULT IN PRODUCT FAILURE. IT ALSO STATES THAT IN THE EVENT OF INADVERTENT ADVANCEMENT OF THE INTRODUCER CANNULA DURING DEPLOYMENT OF THE CURVED CANNULA ASSEMBLY, CARE MUST BE TAKEN TO PREVENT POTENTIAL FURTHER DEVICE DAMAGE. THIS CAN OCCUR IF MALLET STRIKES CONTINUE TO BE DELIVERED WHEN THE GEAR WHEEL IS IN CONTACT WITH THE INTRODUCER CANNULA. THIS SCENARIO CAN CREATE A CONDITION IN WHICH THE INTRODUCER CANNULA ADVANCES ALONG ITS STRAIGHT TRAJECTORY, WHILE THE CURVED CANNULA IS HELD IN THE BONE ALONG ITS CURVED TRAJECTORY. THIS CAN LEAD TO THE CREATION OF A KINK IN THE CURVED CANNULA MATERIAL. IF IT IS SUSPECTED THAT THIS OCCURRED, OR IF RETRACTION OF THE CURVED CANNULA IS DIFFICULT, IT IS RECOMMENDED THAT INTRODUCER CANNULA AND CURVED CANNULA BE REMOVED AS A SINGLE UNIT, RATHER THAN RETRACTING THE CURVED CANNULA BY ITSELF. TECHNICIANS CONFIRMED THROUGH VISUAL INSPECTION THAT THE CURVED CANNULA SHAFT TIP WAS BROKEN. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND PRODUCT LABELLING REVIEW, IT HAS BEEN DETERMINED THAT THE PROBABLE CAUSE WAS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THE DAMAGE WAS LIKELY DUE TO THE USE OF EXCESSIVE FORCE DURING THE PROCEDURE.