ARTHREX

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY/ROTATOR CUFF REPAIR, THE TIP OF THE REPROCESSED ARTHREX SCORPION NEEDLE BROKE OFF INTO THE PATIENT WHILE END-USER WAS TRYING TO PASS A SUTURE THROUGH THE SHOULDER. PER REPORT, THE SURGEON COULD NOT FIND THE TIP AND IT WAS ASSUMED THAT THE TIP THAT BROKE OFF WAS LEFT INSIDE THE PATIENT. DUE TO THE REPORTED EVENT, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. A POTENTIAL ROOT CAUSE OF THE TIP BREAKING IS DESIGN ISSUE (OF THE ORIGINAL EQUIPMENT MANUFACTURER). A DEFINITIVE ROOT CAUSE 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 THAT BROKE OFF INTO THE PATIENT COULD NOT BE FOUND AND WAS REPORTEDLY LEFT INSIDE OF PATIENT.