CORKSCREW, FT SUTURE ANCHOR WITH NEEDLES

Description of Event or Problem

HOSPITAL REPORTED THE PATIENT CAME BACK WITH PAIN, EDEMA AND FEVER APPROXIMATELY 2 MONTHS POST OP. CULTURES REVEALED A METHICILLIN SENSITIVE STAPH AUREUS. IRRIGATION AND DEBRIDEMENT PERFORMED IN 2007. PATIENT WENT HOME WITH A PICC LINE AND INTRAVENOUS ANTIBIOTIC (ANCEF). PER SURGEON, PATIENT HAD A QUESTIONABLE PRE-OP INFECTION. ON FURTHER COMMUNICATION, THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THIS DEVICE IS USED FOR TREATMENT.

Additional Manufacturer Narrative

FURTHER COMMUNICATION WITH ARTHREX REPRESENTATIVE AND SURGERY CENTER'S NURSE INDICATE THE SOURCE OF THE INFECTION REMAINS UNKNOWN. THIS IS THE FOURTH OF FOUR INFECTION CASES INVOLVING THE SAME SURGEON AND THE SAME SURGERY CENTER. THE MEDICAL FACILITY IS STILL INVESTIGATING THESE CASES. REVIEW OF THE STERILITY CERTIFICATION FOR THIS LOT REVEALED NO DISCREPANCIES. PREVIOUS INVESTIGATIONS INDICATE THAT THIS TYPE OF EVENT IS TYPICALLY RELATED TO NOSOCOMIAL INFECTION. HOWEVER, A DEFINITIVE CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.