AMIS MOBILE LEG POSITIONER 2.0 FRAME

Description of Event or Problem

BONE FRACTURE OCCURRED DURING THE EXTERNAL ROTATION OF THE LEG WITH THE AMIS LEG POSITIONER. NO ADDITIONAL TREATMENT WAS PERFORMED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. (B)(6) YEAR-OLD PATIENT WITH POOR BONE QUALITY. IT IS UNKNOWN WHETHER OR NOT THE SURGEON WILL FIX THE FRACTURE.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 21 FEBR 2024. LOT 1213764: (B)(4) ITEM MANUFACTURED AND RELEASED ON 23-JUL-2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT DURING PHA SURGERY ON A 96 YEAR OLD PATIENT, THE TIBIA FRACTURED ON THE DISTAL PART. ACCORDING TO REPORT, THE FRACTURE OCCURED DURING THE EXTERNAL ROTATION OF THE LEG WITH THE AMIS LEG POSITIONER. IT MAY BE POSSIBLE THAT DUE TO THE LOW BONE QUALITY OF THE PATIENT AND THE SMALL OVERALL DIMENSION OF THE TIBIA THE APPLIED TORTIONAL FORCE RESULTED EXCESSIVE.