AR-13991N @SUREFIRE SCORPION NDL

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TIP OF THE SCORPION NEEDLE BROKE OFF DURING A SHOULDER ROTATOR CUFF REPAIR AND FELL INTO THE SURGICAL SITE. ACCORDING TO THE REPORTING FACILITY, THE ENTIRETY OF THE BROKEN SCORPION NEEDLE TIP WAS ABLE TO BE RETRIEVED FROM THE SURGICAL SITE USING AN ARTHROSCOPY GRASPER. NO FURTHER INCIDENT WAS REPORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE INCIDENT AND NO ADDITIONAL ANESTHESIA WAS REQUIRED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT IMPACT OR FOLLOW-UP CARE OCCURRED. THE DEVICE INVOLVED IN THE INCIDENT WAS REPORTEDLY DISCARDED AND NO SAMPLE WAS AVAILABLE TO BE RETURNED FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED AT THIS TIME. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION TO RETRIEVE THE BROKE SCORPION NEEDLE TIP FROM THE SURGICAL SITE, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF THE SCORPION NEEDLE BROKE OFF DURING USE.