AR-13995N MULTIFIRE SCORPION NDL BLACK

Additional Manufacturer Narrative

A TOTAL OF SIXTEEN (16) SAMPLES WERE RETURNED BY THE REPORTING FACILITY. INVESTIGATION OF THE RETURNED SAMPLES WAS COMPLETED ON 20-MAY-2021 AND NO ISSUES WITH THE RETURNED DEVICES WERE OBSERVED. OF NOTE, THE DEFECTIVE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION. TO DATE, NO ADDITIONAL INFORMATION RELATED TO THE REPORTED INCIDENT HAS BEEN RECEIVED. THE REPORTED DEVICE PROBLEM/ISSUE WAS UNABLE TO BE CONFIRMED AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING A RIGHT SHOULDER SCOPE AND ROTATOR CUFF REPAIR PROCEDURE, THE SCORPION NEEDLE BROKE OFF AND FELL INTO THE SURGICAL SITE. DESPITE MULTIPLE GOOD (B)(6) ATTEMPTS THE REPORTING FACILITY WAS UNABLE OR UNWILLING TO PROVIDE ADDITIONAL INFORMATION RELATED TO THE INCIDENT. NO ADVERSE PATIENT IMPACT OR EFFECT WAS ORIGINALLY REPORTED AND NO OTHER DETAILS ARE AVAILABLE AT THIS TIME. NO SAMPLE HAS BEEN RECEIVED FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, 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 SCORPION NEEDLE BROKE OFF DURING PATIENT USE.