ARTHREX

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE REPROCESSED ARTHREX SCORPION NEEDLE'S TIP BROKE OFF INSIDE OF THE PATIENT DURING A ROTATOR CUFF SURGERY. PER REPORT, THE BROKEN TIP WAS SUCCESSFULLY RETRIEVED FROM THE SURGICAL SITE THROUGH AN UNIDENTIFIED METHOD. THERE WAS NO REPORT OF PROLONGED ANESTHESIA, A SERIOUS INJURY OR ANOTHER ADVERSE PATIENT EVENT AT THIS TIME. ANOTHER DEVICE WAS OBTAINED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED. A REVIEW OF THE REPROCESSING RECORD COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE REPROCESSED ARTHREX SCORPION NEEDLE'S TIP BROKE OFF INSIDE OF THE PATIENT. THE BROKEN TIP WAS SUCCESSFULLY RETRIEVED FROM THE SURGICAL SITE.