SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID

Additional Manufacturer Narrative

NO PRODUCT IS BEING RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE. IT APPEARS THE GUIDEWIRE BECAME BENT DURING THE SURGERY, WHICH MAY HAVE CAUSED IT TO BECOME STUCK IN THE SURETAC, BUT THIS CANNOT BE CONFIRMED.

Description of Event or Problem

DURING A ROUTINE SLAP ARTHROSCOPIC REPAIR, A BRIEFING ON HOW TO USE THE RDS SYSTEM WAS GIVEN PRIOR TO SURGERY. DURING THE PROCEDURE, THE TECHNIQUE WAS FOLLOWED AS RECOMMENDED IN THE RELEVANT TECHNIQUE GUIDE. WHILE POUNDING THE IMPLANT INTO THE GLENOID SOME RESISTANCE WAS EXPERIENCED. ONCE THE SURETAC IMPLANT WAS IN A SATISFACTORY POSITION, THE SURGEON ATTEMPTED TO REMOVE THE GUIDE WIRE. CONSIDERABLE FORCE WAS USED TRYING TO REMOVE THE GUIDE WIRE BY PULLING THE WIRE WHILE GRIPPING WITH PLIERS. A DRILL WITH JACOBS CHUCK WAS ATTACHED TO THE DRILL TO DRIVE THE WIRE UNDER POWER TO REMOVE IT. AT THIS POINT, THE GUIDE WIRE SNAPPED. ON X-RAY THE GUIDE WIRE CAN BE CLEARLY SEEN EMBEDDED INTO THE GLENOID AND IT IS BENT IN THE MIDDLE TO AN ANGLE OF APPROXIMATELY 20 DEG. THE SUPERIOR BROKEN END OF THE GUIDE WIRE APPEARS TO BE APPROXIMATELY 2-3MM BELOW THE SURFACE OF THE GLENOID. THE SURGEON DID NOT EXPERIENCE A "SIGNIFICANT" DELAY (>40 MINUTES) TO THE SURGERY.