HIP INSTRUMENTS

Description of Event or Problem

AN INTRAOPERATIVE FRACTURE OCCURRED DURING USE OF AMIS LEG POSITIONER, WHEN THE FOOT IS EXTERNALLY ROTATED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE INTRAOPERATIVE FRACTURE WAS INITIALLY STABILIZED AND LATER DEFINITIVELY TREATED WITH PLATE FIXATION.

Additional Manufacturer Narrative

CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR THE ROOT CAUSE FOR ALL BONE FRACTURES IS THE APPLICATION OF FORCE OR TORQUE BEYOND THE MECHANICAL STRENGTH OF THE BONES. THE AMIS TABLE IS NOT EQUIPPED WITH A SYSTEM THAT PREVENTS EXCESSIVE FORCE TO BE APPLIED BECAUSE THIS FORCE IS EXTREMELY VARIABLE WITH INDIVIDUAL CONDITIONS, PARTICULARLY BONE DENSITY AND STRENGTH, AND CANNOT BE MEASURED IN ADVANCE. IT IS OF COURSE ALSO POSSIBLE THAT THE AMIS SHOE OR THE EXTENSION TABLE ITSELF WERE NOT PROPERLY PLACED ON THE PATIENT, BUT WE HAVE NO INFORMATION ON THIS POSSIBILITY AND THEREFORE WE ARE NOT CONSIDERING IT. THE MOST LIKELY REASON FOR THE FRACTURE IS THE APPLICATION OF EXCESSIVE FORCE OR TORQUE FOR THE INDIVIDUAL PATIENT. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICES COULD BE ASSOCIATED WITH THIS CASE. ROOT CAUSE:SPECIFIC PATIENT CONDITIONS AND UNIQUE SURGICAL FACTORS LIKELY RESULTED IN THE ISSUE REPORTED. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.