ARTHRO SUTURE MANIP *EA

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: INVESTIGATION SUMMARY- THE PRODUCT AND A PHOTOS WERE RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTOS FOUND THE DEVICE SHAFT DEFORMED AT THE DISTAL END. NO OTHER ANOMALIES WERE NOTED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE TIP WAS DEFORMED. NO OTHER ANOMALIES WERE NOTED. THE MANUFACTURER PERFORMED AN INVESTIGATION OF THE DEVICE RETURNED WITH THE FOLLOWING RESULTS: THE DEVICE WAS FOUND TO BE BENT, WHICH CORRELATES WITH THE CUSTOMER¿S COMPLAINT DESCRIPTION. A FUNCTIONAL DEVIATION WAS IDENTIFIED AS A RESULT OF THE DEVICE¿S BENT CONDITION. THE INVESTIGATION WAS CONDUCTED BY A CROSS-FUNCTIONAL TEAM COMPRISING REPRESENTATIVES FROM ENGINEERING, PRODUCTION, QUALITY CONTROL, AND QUALITY ASSURANCE. THE FINDINGS PRESENTED REFLECT THEIR COLLECTIVE ASSESSMENT. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND FOUND TO BE COMPLETE, WITH NO DISCREPANCIES REPORTED OR OBSERVED DURING PRODUCTION. THE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED ACCORDING TO DEVICE MASTER RECORD (DMR) REQUIREMENTS WITH NO DEVIATIONS OBSERVED OR RECORDED. THE FINAL INSPECTION OF THE FINISHED GOODS INCLUDES A 100% VISUAL INSPECTION OF THE DEVICES. ALL UNITS PASSED INSPECTION WITH NO DEVIATIONS OBSERVED OR RECORDED. THE DEVICE IS CLASSIFIED AS REUSABLE, NON POWERED SURGICAL INSTRUMENT. THE IFU ¿CAUTION¿ SECTION CLEARLY STATES TO INSPECT THE DEVICE FOR DAMAGE PRIOR TO USE. REPLACE A DAMAGED, WORN OR BENT INSTRUMENT. DO NOT ATTEMPT TO STRAIGHTEN, SHARPEN OR REPAIR. TRANSPORTATION AND SHIPPING ACTIVITIES AT TAG ARE CARRIED OUT BY EXTERNALLY QUALIFIED COURIER COMPANIES. THE LIKELY ROOT CAUSE APPEARS TO BE DAMAGE RESULTING FROM TRANSPORTATION OR SHIPPING PROCESS CARRIED OUT BY EXTERNAL COURIER, OR BY IMPROPER STORAGE CONDITIONS AT THE CUSTOMER SITE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ARTHRO SUTURE MANIP *EA WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. ¿ BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL CAUSE COULD BE TRACED TO TRANSPORT/STORAGE. 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 DEPUY SYNTHES 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.

Description of Event or Problem

IT WAS REPORTED THAT AFTER PREPARING THE NEW ANCILLARY TOOLS FOR THE ROTATOR CUFFS, AND WHEN OPENING THE PACKAGING OF THE ARTHRO SUTURE MANIP DEVICE IT WAS OBSERVED THAT THE DEVICE WAS BENT IN THE PACKAGING. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE TIP OF THE DEVICE WAS DEFORMED. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.