SUTURE BUTTON 3.5MM, STERILE

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR, THE SUTURE BROKE AS THE SURGEON WAS PASSING THE SUTURE THROUGH THE BUTTON. THE SURGERY WAS DELAYED APPROXIMATELY 45 MINUTES BUT NO ADD'L ADVERSE CONSEQUENCES WERE REPORTED WITH THE PT. THE SURGERY WAS COMPLETED WITH A DIFFERENT PRODUCT. THIS DEVICE IS USED FOR TREATMENT.

Additional Manufacturer Narrative

DEVICE EVALUATION REVEALED THAT ONLY THE BUTTON WAS RETURNED. A NEW SUTURE FROM STOCK WAS USED TO TEST AND PASSED THROUGH THE BUTTON WITHOUT PROBLEMS. THE SUTURE REMAINED INTACT. THE BUTTON HAD DEEP SCRATCHES AND GOUGES WHICH EVIDENCE CONTACT WITH A SHARP OBJECT. THE CAUSE OF THE COMPLAINANT'S EVENT, HOWEVER, COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT EVALUATION OF THE ACTUAL SUTURE INVOLVED.