STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT A STERNAL ZIPFIX CABLE BROKE DURING TIGHTENING. THERE WERE NO FRAGMENTS GENERATED, THE EVENT OCCURRED INTRA-OPERATIVELY DURING A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, RESULTING IN A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: H4. CORRECTED: G1. H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE FOUND THAT STERNAL ZIPFIX CABLE TIE W/NEEDLE HAD THE END WITH THE NEEDLE CUT-OFF, MOST LIKELY AFTER TIGHTENING PER THE SURGICAL PROCEDURE AND THE LOOP BROKEN. NO OTHER ISSUES WERE OBSERVED ON THE RETURNED DEVICE. IN ADDITION, A SECTION OF THE STERNAL ZIPFIX CABLE TIE W/NEEDLE WAS NOT RETURN. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES LIKE USAGE OF EXCESSIVE FORCE DURING THE TENSIONED. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. A DIMENSIONAL INSPECTION FOR THE STERNAL ZIPFIX CABLE TIE W/NEEDLE PEEK 2 WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS UNABLE TO PERFORMED AS THE IMPLANT WAS RECEIVED LOCKED INTO THE HEAD. PER STERNAL ZIPFIX SURGICAL TECHNIQUE GUIDE SE_839363 REV. AB. PRECAUTIONS: DO NOT DAMAGE THE IMPLANT TEETH AND LOCKING HEAD BY MANIPULATING WITH INSTRUMENTS. ENSURE THAT THE LOCKING HEAD OF THE IMPLANT IS FREE OF SOFT TISSUE AND/OR SURGICAL MATERIAL THAT COULD PREVENT LOCKING OF THE IMPLANT. HANDLE IMPLANTS CAREFULLY, ESPECIALLY NEEDLES, TO AVOID DAMAGING CRITICAL STRUCTURES, SOFT TISSUE AND/OR HAND GLOVES ANDLE IMPLANTS CAREFULLY, ESPECIALLY NEEDLES, TO AVOID DAMAGING CRITICAL STRUCTURES, SOFT TISSUE AND/OR HAND GLOVES. PRECAUTIONS: AVOID EXCESSIVE FORCE WHEN TIGHTENING IMPLANT. DO NOT USE FORCEPS TO TIGHTEN IMPLANT. DAMAGE RESULTING FROM EXCESSIVE FORCE OR FORCEPS MAY CAUSE IMPLANT FAILURE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE STERNAL ZIPFIX CABLE TIE W/NEEDLE PEEK 5 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. 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. PRODUCT CODE: 08.501.001.05S-15. LOT NUMBER: 8626P98. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 07 MAY 2024 . MANUFACTURING SITE: PURCHASED ITEM, DELIVERED BY SAMAPLAST, SHIPPED BY JABIL BETTLACH,. EXPIRY DATE:01 MAR 2029. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D9 THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.