TORNIER SIMPLICITI NUCLEUS SIZE 2

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. 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. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT; THE REVISION SURGERY WAS PERFORMED IN WHICH ANATOMIC SHOULDER WAS REVISED TO REVERSE DUE TO SUBSCAPULARIS REPAIR FAILING. NO IMPLANT FAILURE WAS NOTED.

Additional Manufacturer Narrative

THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

Description of Event or Problem

IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED IN WHICH ANATOMIC SHOULDER WAS REVISED TO REVERSE DUE TO SUBSCAPULARIS REPAIR FAILING. NO IMPLANT FAILURE WAS NOTED.