CORKSCREW, FT SUTURE ANCHOR WITH NEEDLES

Description of Event or Problem

HOSPITAL REPORTED THE PATIENT PRESENTED WITH INFECTION OF THE RIGHT SHOULDER APPROXIMATELY 3 WEEKS POST OP. PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT, AND HARDWARE REMOVAL IN 2006. PATIENT WAS TREATED WITH ANTIBIOTICS FOR APPROXIMATELY 12 WEEKS AND ONCE INFECTION RESOLVED, THE PATIENT RETURNED IN 2007 FOR A REVISION OF THE ROTATOR CUFF. 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 FIRST 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.