FINGER JOINT IMPLANT W/ GROMMETS 3

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. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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 DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE JOINTS FROM II THROUGH V WITH SWANSON IMPLANTS. 9 WEEKS AFTER HAND SURGERY, FIST CLOSURE IS IMPOSSIBLE. THE FINGER BASE JOINTS ARE HARDLY MOVABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE JOINTS FROM II THROUGH V WITH SWANSON IMPLANTS. 9 WEEKS AFTER HAND SURGERY, FIST CLOSURE IS IMPOSSIBLE. THE FINGER BASE JOINTS ARE HARDLY MOVABLE.

Additional Manufacturer Narrative

DEVICE WILL NOT BE RETURNED AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED IN PATIENT.