KNOTLESS T-ROPE SYN-DESMOSIS REPR TI

Description of Event or Problem

IT WAS REPORTED THAT DURING A TIBIA SURGERY THE SUTURE COULD NOT BE PULLED THROUGH THE GUIDE WIRE. WHEN THE SURGEON PULLED ON THE SUTURE, THE SUTURE TIGHTENED BEHIND THE BUTTON AND BECAME KNOTTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.