ACCUPORT

Additional Manufacturer Narrative

THE SOURCE OF THIS COMPLAINT WAS FROM AN EVENT THAT OCCURRED IN THE UNITED KINGDOM. ON (B)(6) 2019, IT WAS REPORTED THAT THE TIP OF THE ACCUPORT CANNULA BROKE OFF WHEN EXTRACTING IT. PER THE REPORTED INFORMATION, UPON REINSERTING THE STYLUS, THE SURGEON REALIZED THAT THEY WERE UNABLE TO PUSH IN THE STYLUS ALL THE WAY BACK IN SO THAT THE WINGS LOCKED INTO THEIR ORIGINAL PLACE. PER THE EMEA SUBCHONDROPLASTY SCP KNEE SURGICAL TECHNIQUE GUIDE, PLUNGE THE STYLUS BACK INTO THE CANNULA TO INJECT RESIDUAL ACCUFILL BSM; INSERT THE STYLUS FULLY UNTIL LOCKING WINGS ARE SECURED TO THE HUB. THEREFORE THE SURGEON WAS UNABLE TO USE THE DRILL TO EXTRACT THE CANNULA, SO HAD TO TRY AND EXTRACT IT BY HAND. DURING THIS EXTRACTION THE TIP OF THE CANNULA BROKE OFF. THE TIP WAS WELL IN THE FEMORAL CONDYLE SO THE SURGEON FELT IT BEST TO LEAVE IT IN SITU RATHER THAN TRY TO EXTRACT IT. THERE WERE NO OTHER INTRAOPERATIVE COMPLICATIONS OR NOTED CONTRIBUTING FACTORS TO THE EVENT. THE MOST LIKELY ROOT CAUSE IS AN UNINTENDED USE ERROR CONTRIBUTING TO THE EVENT. THE EVENT WAS SENT TO THE MANUFACTURER ON (B)(6) 2019. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION; HOWEVER, A RETAIN WAS CONDUCTED ON THE SAME RAW MATERIAL LOT (LOT 38224) AND THE DEFECT WAS NOT OBSERVED. THE DHR FOR THE FINISHED GOODS LOT WAS REVIEWED, AND NO ANOMALIES RELATED TO THE COMPLAINT CONDITION WERE NOTED.

Description of Event or Problem

CANNULA BROKEN AND TIP REMAINS IN THE PATIENT.

Additional Manufacturer Narrative

THE SOURCE OF THIS COMPLAINT WAS FROM AN EVENT THAT OCCURRED IN THE (B)(6). ON (B)(6) 2019, IT WAS REPORTED THAT THE TIP OF THE ACCUPORT CANNULA BROKE OFF WHEN EXTRACTING IT. PER THE REPORTED INFORMATION, UPON REINSERTING THE STYLUS, THE SURGEON REALIZED THAT THEY WERE UNABLE TO PUSH IN THE STYLUS ALL THE WAY BACK IN SO THAT THE WINGS LOCKED INTO THEIR ORIGINAL PLACE. THEREFORE THE SURGEON WAS UNABLE TO USE THE DRILL TO EXTRACT THE CANNULA, SO HAD TO TRY AND EXTRACT IT BY HAND. DURING THIS EXTRACTION THE TIP OF THE CANNULA BROKE OFF. THE TIP WAS WELL IN THE FEMORAL CONDYLE SO THE SURGEON FELT IT BEST TO LEAVE IT IN SITU RATHER THAN TRY TO EXTRACT IT. THERE WERE NO OTHER INTRAOPERATIVE COMPLICATIONS OR NOTED CONTRIBUTING FACTORS TO THE EVENT. THE EVENT WAS SENT TO THE MANUFACTURER ON (B)(6) 2019. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION. THE DHR FOR THE FINISHED GOODS LOT WAS REVIEWED, AND NO ANOMALIES RELATED TO THE COMPLAINT CONDITION WERE NOTED. ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE ABOUT THE EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

CANNULA BROKEN AND TIP REMAINS IN THE PATIENT.