IDEAL SHUTTLE 45 DEGREES RIGHT -G

Description of Event or Problem

REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT TWO IDEAL SHUTTLE 45 DEGREES RIGHT-G DEVICES WERE ¿BENT¿ OUT OF PACKAGING. ACCORDING TO THE REPORTER, ONE DEVICE BENT FURTHER WHEN THE SURGEON ATTEMPTED TO USE IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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 ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. INVESTIGATION SUMMARY THE PRODUCT HAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER A PHOTO WAS PROVIDED FOR REVIEW. ¿ THE PHOTO INVESTIGATION REVEALED THAT IDEAL SHUTTLE 45 DEGREES RIGHT -G WAS DEFORMED AT THE TIP OF THE DEVICE. THE MANUFACTURER PERFORMED AN INVESTIGATION OF THE PHOTO PROVIDED WITH THE FOLLOWING RESULTS: THE DEVICE HAD A BENT TIP. THE SUPPLIER PERFORMED AN INVESTIGATION WITH THEIR ENGINEERING, PRODUCTION, QC AND QA PERSONNEL. ACCORDING TO THE IFU INSTRUCTIONS AXIAL FORCE MUST NOT BE APPLIED ON THE SUTURE SHUTTLE. IN THE PRECAUTIONS IN THE IFU SAYS TO NOT APPLY AXIAL OR BENDING FORCES TO THE NEEDLE SHAFT. IN THE DESCRIPTION OF THIS DEVICE, IT IS CLEARLY STATED THAT THE SUTURE SHUTTLE IS TO BE USED ONLY FOR PASSING SUTURE THROUGH TISSUE. IN THE CONTRADICTIONS SECTION ALSO WARS NOT TO USE ON BONE OR OTHER SIMILAR TISSUES. THE INSTRUCTIONS FOR USE PROVIDE THE RIGHT WAY OF USING THE DEVICE. IN ALL THE INSTRUCTIONS THE DEVICE MUST BE USED WITH CARE AND TO FOLLOW THE INSTRUCTIONS. THIS DEVICE AND THE MANUFACTURING PROCESSES HAVE BEEN VALIDATED AND APPROVED. AS TO RISK ANALYSIS REPORT, THE BENDING OF THE DEVICE HAS LITTLE POTENTIAL OF INJURY. AFTER REVIEWING ALL THE ABOVE INFORMATION, THE DESCRIPTION OF THE COMPLAINT AND THE INFORMATION IN THE IFU, THE INVESTIGATION TEAM HAS CONCLUDED THERE WAS A MISUSE OF THE DEVICE THAT CAUSED THIS FAILURE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE IDEAL SHUTTLE 45 DEGREES RIGHT -G WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL CAUSE COULD BE TRACED TO MISS USE OF THE DEVICE. 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.

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 MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE TIP DEFORMED. NO OTHER ANOMALIES WERE NOTED. THE DEVICE WAS SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. THE MANUFACTURER PERFORMED AN EVALUATION WITH THE FOLLOWING RESULTS: THE DEVICE WAS RECEIVED FOR EVALUATION. THE PROBLEM WAS CONFIRMED, AND THE TIP WAS BENT. THE DEVICE WAS CHECKED, AND IT STILL MEETS THE BENDING FORCE SPECIFICATIONS, IT WAS TESTED FOR THE BENDING FORCE AND THE RESULTS MEETS THE V&V REQUIREMENTS (MINIMUM OF 29.4N), THE RESULTS WERE 30N. NO DIMENSIONAL ISSUES WERE DETECTED. THE DHR WAS CHECKED AND NO NON CONFORMANCES WERE FOUND. THE SUPPLIER PERFORMED AN INVESTIGATION WITH ENGINEERING, PRODUCTION, QC AND QA DEPARTMENTS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AXIAL FORCE MUST NOT BE APPLIED TO THE SUTURE SHUTTLE. IN THE PRECAUTIONS IN THE IFU SAYS TO DO NOT APPLY AXIAL OR BENDING FORCES TO THE NEEDLE SHAFT. THE DESCRIPTION OF THIS DEVICE IT IS CLEARLY STATED THAT THE SUTURE SHUTTLE IS TO BE USED ONLY FOR PASSING SUTURE THROUGH TISSUES. IN THE CONTRADICTION SECTION ALSO WARNS NOT TO USE BONE OR OTHER SIMILAR TISSUES. IFU GUIDES THE RIGHT WAY OF USING THE DEVICE. IN ALL THE INSTRUCTIONS, THE DEVICE MUST BE USED WITH CARE AND TO FOLLOW INSTRUCTIONS. THE DEVICE AND THE MANUFACTURING PROCESS HAVE BEEN VALIDATED AND APPROVED. AS TO RISK ANALYSIS REPORT, THE BENDING OF THE DEVICE HAS LITTLE POTENTIAL OF INJURY. AFTER REVIEWING ALL THE INFORMATION, THE INVESTIGATION TEAM HAS CONCLUDED THERE WAS A MISUSE OF THE DEVICE THAT CAUSED THE REPORTED FAILURE. THE ROOT CAUSE CAN BE TRACED TO MISUSE OF THE DEVICE. 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 MISUSE OF THE DEVICE. 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. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.