IDEAL SHUTTLE 45 DEGREES RIGHT -G

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND THAT THE TIP OF THE WIRE IS BROKEN. NO OTHER ANOMALIES WERE NOTED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE IDEAL SHUTTLE 45 DEGREES RIGHT-G WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE; EXCESSIVE FORCE MAY WAS APPLIED TO THE GRASPING WIRE DURING MANIPULATION; THEREFORE, THE GRASPING WIRE WAS DAMAGED. AS PER IFU, DO NOT APPLY EXCESSIVE AXIAL OR BENDING FORCES TO THE NEEDLE SHAFT OR SHUTTLE DURING USE, AS EXCESSIVE FORCE MAY LIMIT THE FUNCTION OF THE DEVICE OR CAUSE THE DEVICE TO BEND, DEFORM OR BREAK. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ROTATOR CUFF REPAIR SURGICAL PROCEDURE WHILE USING THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.