KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE BUTTON FLIPPED PREMATURELY UNDER THE CLAVICULA AND COULD NOT BE POSITIONED CORRECTLY ANYMORE. 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.