BIO-PREP BONE PREPARATION KIT

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THAT PART OF THE INSERTER ATTACHMENT BECAME LODGED IN THE FEMORAL CANAL AND BROKE AFTER MULTIPLE ATTEMPTS TO REMOVE IT. SURGEONS WERE UNABLE TO REMOVE IT, LEAVING 5 CM OF THE INSERTER TOOL WITHIN THE FEMUR. X-RAY WAS COMPLETED TO ENSURE NO INJURY/FRACTURE TO FEMUR OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO FURTHER MEDICAL INTERVENTIONS WERE REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.