PERFORM NUCLEUS FC SIZE 1 - ANATOMIC

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL MANUFACTURING OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED THE INVESTIGATION WILL BE REASSESSED

Description of Event or Problem

SUBJECT: (B)(6). PERFORM HUMERAL SYSTEM STUDY (PHS). UNEXPECTED PAIN NOT RELATED TO SURGICAL RECOVERY. SUBJECT CONTACTED SURGEON'S OFFICE WITH COMPLAINTS OF PAIN. SUBJECT COMPLETED A COURSE OF PHYSICAL THERAPY AND UNDERWENT AN ULTRASOUND WHICH SHOWED MILD BURSITIS. SUBJECT WAS STILL EXPERIENCING PAIN AT TWO-YEAR POST-OP VISIT AND RECEIVED A STEROID INJECTION.