KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. -VISUAL INSPECTION OF THE KNOTLESS AC TIGHTROPE® OPEN REPAIR IMPLANT, IDENTIFIED THAT THE THREADED DISTAL END OF THE SHAFT WAS STRIPPED, THE PEC BUTTON WAS DISASSEMBLED FROM THE TIP OF THE INSERTER, WITH SUTURES AND PLATE BUTTON. -FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE NOT SPECIFIED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREPARATION, MISALIGNMENT OF INSERTION, AND/OR PRYING/LEVERAGING OF THE DEVICE DURING INSERTION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SHAFT GOT BENT AND COULD NOT BE PUSHED IN. 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.