AEQ. RETRACTOR SHOULDER SYSTEM

Additional Manufacturer Narrative

SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PLASTIC DARRACH RETRACTOR BROKE DURING SHOULDER REPLACEMENT OPERATION. SURGEON WAS ATTEMPTING TO DISLOCATE SHOULDER, AND THE RETRACTOR BROKE IN TWO PIECES.

Additional Manufacturer Narrative

CORRECTION: H6 HEALTH IMPACT CODE. THE REPORTED EVENT WAS CONFIRMED SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RETURNED DEVICE IS CLEARLY BROKEN AT THE DISTAL END. THE BREAKAGE AREA EXHIBITS SIGNS OF STATIC FAILURE WITH EVIDENCE OF PLASTIC DEFORMATIONS AND STRAIN AT THE BREAKAGE POINT. THIS IS FOLLOWED BY SIGNS OF INSTANTANEOUS BRITTLE FRACTURE EVIDENCED BY THE SMOOTH, SHINY APPEARANCE AT THE BREAKAGE POINT. 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. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A COMBINATION OF TYPICAL WEAR AND USE. THE FAILURE WAS CAUSED BY NORMAL AND FREQUENT USAGE. THE DEVICE IS USED TO MOVE AND HOLD TYPICALLY TENSE SOFT TISSUE SO THE SURGEON CAN ACCESS GLENOHUMERAL JOINT. OVER TIME, THE COMBINATION OF PRESSURE EXERTED ON THE DEVICE AND MULTIPLE CLEANING/STERILIZATION CYCLES, CAN RESULT IN THE WEAKING OF THE MATERIAL RESULTING IN THE EVENT NOTED IN THIS COMPLAINT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT THE PLASTIC DARRACH RETRACTOR BROKE DURING SHOULDER REPLACEMENT OPERATION. SURGEON WAS ATTEMPTING TO DISLOCATE SHOULDER, AND THE RETRACTOR BROKE IN TWO PIECES.