IDEAL SUTURE SHUTTLE 45 DEGREES LEFT

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE PRODUCT HAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER, A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND THE GUIDEWIRE PUT OF THE HANDLE AND THE LOOP BROKEN. NO OTHER ANOMALIES WERE NOTED. AS THE DEVICE SHOWED SIGNS OF USE, THE ALLEGATION OF DAMAGE PRIOR TO USE COULD NOT BE CONFIRMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO THE PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION BEFORE THE PROCEDURE; HOWEVER, MULTIPLE FACTORS ARE ASSOCIATED WITH THIS TYPE OF FAILURE, THE COMPLAINT DEVICE NEEDS TO BE PHYSICALLY EVALUATED IN ORDER TO DETERMINE WHY THE CUSTOMER EXPERIENCED THE FAILURE. AS PER THE INSTRUCTIONS FOR USE, THE SHUTTLE SHOULD BE RETRACTED WHEN PUSHING THE NEEDLE THROUGH TISSUE. FAILURE TO RETRACT THE SHUTTLE COULD RESULT IN DEVICE DAMAGE AND/OR PATIENT INJURY. 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. DEVICE HISTORY REVIEW: THERE WAS NO NON-CONFORMANCE REGARDING THIS LOT.

Description of Event or Problem

IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE GUIDEWIRE PUT OF THE HANDLE AND THE LOOP OF THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE WAS BROKEN. IT WAS NOTED IN THE SERVICE ORDER THAT THE SHUTTLE RING WAS FOUND TO BE LOOSE IN THE PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.