CORKSCREW, FT SUTURE ANCHOR WITH NEEDLES

Description of Event or Problem

PATIENT UNDERWENT LEFT SHOULDER VIDEOARTHROSCOPY WITH ACROMIOPLASTY AND OPEN ROTATOR CUFF REPAIR. PATIENT CAME BACK TO DOCTOR'S OFFICE APPROXIMATELY ONE MONTH POST OP WITH PAIN. DRAINAGE AND REDNESS AT OPERATIVE SITE. PATIENT WAS BELIEVED TO HAVE SUPERFICIAL INFECTION AND WAS STARTED ON ANTIBIOTICS AND NO CULTURE WAS OBTAINED. PATIENT SUBSEQUENTLY SUFFERED WOUND DEHISCENCE AND UNDERWENT IRRIGATION AND DEBRIDEMENT (I&D) AT THE HOSPITAL AT AN UNKNOWN DATE. IT IS ALSO UNKNOWN IF THE IMPLANT WAS REMOVED. ON FURTHER COMMUNICATION WITH THE SURGERY CENTER, 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 SECOND 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.