ARTHREX SUTURELASSO¿ SD, 25 DEGREE TIGHT CURVE LEFT, WIRE LOOP, (GREEN) 1.8MM

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE THREADING THE WIRE FOR THE ARTHREX SUTURE LASSO, THE WAX COATING ON THE WIRE SCRAPPED OFF AND FELL INTO SURGICAL SITE. REPORTEDLY, A GRASPER WAS USED TO RETRIEVE THE WIRE RESIDUES FROM THE SURGICAL SITE; HOWEVER, IT WAS NOT SURE WHETHER ALL PIECES WERE RETRIEVED. GENERAL ANESTHESIA WAS USED AND PER REPORT, THE PROCEDURE WAS EXTENDED 25 MINUTES DUE TO THE REPORTED INCIDENT. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT, 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 WHILE THREADING THE WIRE FOR THE ARTHREX SUTURE LASSO, THE WAX COATING ON THE WIRE SCRAPPED OFF AND FELL INTO SURGICAL SITE.