FINGER JOINT IMPLANT W/ GROMMETS 4

Additional Manufacturer Narrative

CORRECTION: B2 - OUTCOMES ATTRIBUTED TO AE, H6 (DEVICE, METHOD & RESULTS) CODES. THE REPORTED EVENT COULD BE CONFIRMED BASED ON INSPECTION OF RETURNED PRODUCT. THE DEVICE INSPECTION REVEALED THAT A VISUAL INSPECTION OF RETURNED DEVICE CONFIRMS THAT ONE OF THE STEM IS BROKEN OFF. THE FRACTURE SURFACE SUGGESTS A CLEAN FRACTURE SUGGESTING SUDDEN BREAKAGE. 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 ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

SWANSON FLEXSPAN FINGER JOINT IMPLANT BROKE. ORIGINAL SURGERY WENT WELL. PATIENT WAS DOING WELL POSTOP, GOING TO PHYSICAL THERAPY, NO TRAUMA OR ACCIDENT HAPPENED TO RELATED FINGER. PATIENT STARTED HAVING PAIN, HAD A FOLLOW UP X-RAY AND THE BROKEN IMPLANT WAS SEEN ON X-RAY.

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

SWANSON FLEXSPAN FINGER JOINT IMPLANT BROKE. ORIGINAL SURGERY WENT WELL. PATIENT WAS DOING WELL POSTOP, GOING TO PHYSICAL THERAPY, NO TRAUMA OR ACCIDENT HAPPENED TO RELATED FINGER. PATIENT STARTED HAVING PAIN, HAD A FOLLOW UP X-RAY AND THE BROKEN IMPLANT WAS SEEN ON X-RAY.