IDEAL SUTURE SHUTTLE 90 DEGREES

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. H11 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

Description of Event or Problem

IT WAS REPORTED THAT UPON INSPECTION OF THE PRODUCTS PRIOR TO OPENING THE PACKAGING, IT WAS FOUND THAT THE PRODUCT INFORMATION ON THE FRONT OF THE OUTER PACKAGING WAS CORRECT, THE CODE IS IDEAL SUTURE SHUTTLE 90 DEGREES UP, HOWEVER, THE PRODUCT INFORMATION ON THE BACK OF THE OUTER PACKAGING WAS INCORRECT, THE CODE WAS IDEAL SUTURE SHUTTLE 45 DEGREES LEFT. IT WAS FURTHER OBSERVED THAT THE LABEL AT THE SEAL WAS ALSO INCORRECT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE 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 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. H11 ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

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. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE PRODUCT AND A VIDEO WERE PROVIDED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED VIDEO FOUND THAT THE PRODUCT WAS NOT OPENED AND THE LABEL INFORMATION ON THE BACK OF THE OUTER PACKAGING WAS INCORRECT, THE CODE DOES NOT CORRESPOND WITH THE PRODUCT IDEAL SUTURE SHUTTLE 90 DEGREES. NEVERTHELESS, THE LABEL ON THE FRONT OF THE OUTER PACKAGING WAS CORRECT. NO OTHER ANOMALIES WERE NOTED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE PRODUCT WAS NOT OPENED AND THE LABEL INFORMATION ON THE BACK OF THE OUTER PACKAGING WAS INCORRECT, THE CODE DOES NOT CORRESPOND WITH THE PRODUCT IDEAL SUTURE SHUTTLE 90 DEGREES. NEVERTHELESS, THE LABEL ON THE FRONT OF THE OUTER PACKAGING WAS CORRECT. NO OTHER ANOMALIES WERE NOTED. THE MANUFACTURER PERFORMED AN INVESTIGATION OF THE PHOTOS PROVIDED WITH THE FOLLOWING RESULTS: ¿EVALUATION/INVESTIGATION: ALL MANUFACTURING AND DESIGNS PROCESSES AT TAG FOR THIS DEVICE ARE FULLY VALIDATED AND APPROVED. THERE IS NO REMAINING INVENTORY OF LOT# 24R23 AT TAG. INITIAL FINDINGS: THE NON-CONFORMANCE WAS IDENTIFIED DURING THE INSPECTION OF THE GOODS; THEREFORE, NO ASSOCIATED MEDICAL PROCEDURE IS APPLICABLE. THE DEVICE DID NOT REACH AN END USER OR PATIENT, AND AS A RESULT, THE CASE IS CLASSIFIED AS NOT A SAFETY ISSUE AND REPORTING TO REGULATORY AUTHORITIES IS NOT REQUIRED. THE DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED AND FOUND TO BE COMPLETE, WITH NO DISCREPANCIES REPORTED OR OBSERVED DURING PRODUCTION. ALL REQUIREMENTS AND STEPS OUTLINED IN THE DEVICE MASTER RECORD (DMR) WERE APPROPRIATELY FOLLOWED, EXECUTED, AND DOCUMENTED IN ACCORDANCE WITH PROCEDURAL REQUIREMENTS. LOT# 24R23 SUCCESSFULLY PASSED ALL REQUIRED INSPECTIONS WITH NO REPORTED DEVIATIONS, INDICATING IT MET ALL QUALITY AND COMPLIANCE STANDARDS AT THE TIME OF RELEASE. LABEL ACCOUNTABILITY WAS PERFORMED IN ACCORDANCE WITH TAG FORM. IN ADDITION TO THE SHELF BOX LABEL, THE DEVICE INCLUDES A POUCH LABEL WITH ALL NECESSARY IDENTIFICATION INFORMATION. THEREFORE, THE DEVICE REMAINS LABELED, AND THE RISK TO THE END USER OR PATIENT IS CONSIDERED VERY LOW. ROOT CAUSE ANALYSIS: THE PRIMARY ROOT CAUSE WAS IDENTIFIED USING FISHBONE METHODOLOGY: MAN ¿ APPLICATION ERROR: INSUFFICIENT PACKAGING PROCESS, LABEL ACCOUNTABILITY BY THE PACKING EMPLOYEE, AND INSPECTION BY THE QC INSPECTOR FOLLOWING THE PACKAGING STAGE, LIKELY DUE TO HASTE. THE INADEQUATE PACKAGING PROCESS ALLOWED A NON-CONFORMING PRODUCT TO GO UNDETECTED, LEADING TO THE REPORTED NON-CONFORMANCE. CONCLUSION: THE EVENT IS DETERMINED TO BE JUSTIFIED AND CLASSIFIED AS A SPORADIC, SINGLE OCCURRENCE. NO NEW FAILURE MODES OR HAZARDS WERE IDENTIFIED. THE REPORTED NON-CONFORMANCE RELATES TO A LABELING ISSUE AND HAS NO IMPACT ON DEVICE PERFORMANCE OR PATIENT SAFETY. ANY FAILURE TREND WILL BE MONITORED CONTINUOUSLY TO BETTER UNDERSTAND THE ISSUE AND TO SUPPORT ONGOING QUALITY IMPROVEMENT OF THE DEVICE. CORRECTIVE ACTIONS TAKEN: THE PROCEDURE FOR LABEL ISSUING AND TRACEABILITY WAS RECENTLY UPDATED. THE REVISED VERSION INCLUDES MORE DETAILED AND ROBUST EXPLANATIONS OF THE METHODS INVOLVED, AS WELL AS CLEARER DEFINITIONS OF RESPONSIBILITIES AT EACH STAGE OF THE PROCESS. THE PROCEDURE ¿ LINE CLEARANCE PROCEDURE WAS RECENTLY UPDATED. THE REVISED VERSION PROVIDES MORE DETAILED AND ROBUST EXPLANATIONS OF THE METHODS INVOLVED, WITH CLEARER DEFINITIONS OF LINE CLEARANCE METHOD FOR EACH PRODUCTION DEPARTMENT, PARTICULARLY EMPHASIZING THE PACKAGING DEPARTMENT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE IDEAL SUTURE SHUTTLE 90 DEGREES WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL CAUSE IS TRACED TO MAN APPLICATION ERROR, SUCH INSUFFICIENT PACKAGING PROCESS, LABEL ACCOUNTABILITY BY THE PACKING EMPLOYEE, AND INSPECTION BY THE QC INSPECTOR FOLLOWING THE PACKAGING STAGE. THE PRODUCT ISSUE HAS BEEN ADDRESSED THROUGH SUPPLIER QUALITY SYSTEM. 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. H11 ADDITIONAL NARRATIVE: CORRECTION E1: PLEASE NOTE THAT THE ACCOUNT NAME HAS BEEN UPDATED ACCORDINGLY.