ARTHREX

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TIP OF THE REPROCESSED ARTHREX SCORPION¿ SUTURE PASSER (BLUE) BROKE OFF INTO THE PATIENT DURING AN UNIDENTIFIED LEFT SHOULDER SURGERY. REPORTEDLY, THE INCIDENT HAPPENED WHILE TRYING TO PASS A SUTURE THROUGH THE SHOULDER. IT WAS ADDED THAT THE SURGEON COULD NOT FIND THE TIP AND ASSUMED IT WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS NOTIFIED POST-OP AND REPORTEDLY REFUSED AN X-RAY TO DETERMINE IF THE TIP WAS RETAINED IN THE SHOULDER. DUE TO THE REPORTED EVENT, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS PERFORMED AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. A ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF THE REPROCESSED ARTHREX SCORPION¿ NEEDLE PASSER BROKE OFF INTO THE PATIENT AND COULD NOT BE FOUND.