SWANSON FINGER JOINT 1 W/O GROMMETS

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD A SWANSON MCP PIP IMPLANTED IN THEIR FINGER. A FEW MONTHS LATER IT WAS REPORTED THAT THE PATIENT HAS A RARE FUNGAL INFECTION. THE INFECTION IS NOT AT THE WOUND. THE HOSPITAL DOES NOT BELIEVE THE INFECTION IS SURGERY RELATED, AND DOES NOT BELIEVE THE PATIENT WOULD HAVE CONTRACTED IT THROUGH THEIR OWN ACTIONS. THE PATIENT UNDERWENT A REVISION.

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 ON A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

CORRECTION: D4 CAT #, D4 LOT NUMBER. THE REPORTED EVENT COULD BE CONFIRMED BASED ON REVIEW OF THE X-RAY IMAGES AND ASSESSMENT FROM A MEDICAL PROFESSIONAL. UPON FURTHER INVESTIGATION OF THE X-RAY IMAGES BY HEALTHCARE PROFESSIONALS THE FOLLOWING WAS OBSERVED: THE X-RAY IMAGES CONFIRM THE EVENT BY SHOWING OSTEOLYSIS AND MALALIGNMENT OF THE PIP III JOINT OF THE RIGHT HAND. THE EARLY ONSET OF OSTEOLYSIS RISES THE SUSPICION OF AN INFECTION. X-RAYS ARE, HOWEVER, NOT THE DIAGNOSTIC TOOL TO DETERMINE THE KIND OF MICRO-ORGANISMS CAUSING THE INFECTION. THIS IS TYPICALLY DONE IN THE MICROBIOLOGY LAB WHERE MICROORGANISMS CAN BE CULTURED FROM INTRAOPERATIVE TISSUE AND/OR FLUID SPECIMEN. REGARDING THE CAUSE OF INFECTION, THERE ARE NO SPECIFIC FACTORS THAT ARE RELATED TO THIS INFECTION, EXCEPT FOR THE FACT THAT PATIENTS WITH A FORM OF IMMUNOSUPPRESSION ARE MORE SUSCEPTIBLE FOR INFECTIONS IN GENERAL AND FOR FUNGAL INFECTIONS SPECIFICALLY. A MICROBIOLOGIST REVIEWED THE STERILIZATION PROCEDURES, ENVIRONMENTAL MONITORING, BIOBURDEN DATA AND THE DHR AND NOTED: THE SUBJECT DEVICE WAS PACKAGED ACCORDING TO ESTABLISHED DESIGN AND PROCESS SPECIFICATIONS AND WAS STERILIZED ACCORDING TO PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES COULD BE FOUND. AS NOTED BY A MEDICAL PROFESSIONAL, PATIENTS WITH RHEUMATOID ARTHRITIS ARE AT HIGHER RISK FOR FUNGAL INFECTIONS BECAUSE OF BOTH THEIR DISEASE AND THE IMMUNOSUPPRESSIVE THERAPIES THEY OFTEN RECEIVE. HOWEVER, 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 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. 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 PATIENT HAD A SWANSON MCP PIP IMPLANTED IN THEIR FINGER. A FEW MONTHS LATER IT WAS REPORTED THAT THE PATIENT HAS A RARE FUNGAL INFECTION. THE INFECTION IS NOT AT THE WOUND. THE HOSPITAL DOES NOT BELIEVE THE INFECTION IS SURGERY RELATED, AND DOES NOT BELIEVE THE PATIENT WOULD HAVE CONTRACTED IT THROUGH THEIR OWN ACTIONS. THE PATIENT UNDERWENT A REVISION.