STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK

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: D9 H3, H6: 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.

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. H3, H4, H6 THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE TWO RETURNED SAMPLE REVEALED THAT THERE WERE NO DAMAGE OR DEFECT WITH THE STERNAL ZIPFIX CABLE TIE W/NEEDLE PEEK 2. THE DEVICES WERE RECEIVED IN THEIR ORIGINAL PACKAGING, NEW AND SEALED. THE COMPLAINT DEVICE ISSUE WAS NOT RECEIVED FOR EVALUATION BECAUSE IT WAS NOT RETURNED BY THE HOSPITAL, AS MENTIONED IN THE EVENT DESCRIPTION. HE RETURNED 2 BAND FROM SAME BATCH. IN ADDITION, THE CONTENTS OF THE BOX ARE 20 UNITS. PER THE SURGICAL TECHNIQUE GUIDE STERNAL ZIPFIX STG SE_839363 REV. AB PAGE 6 AND 10 PRECAUTIONS: HANDLE IMPLANTS CAREFULLY, ESPECIALLY NEEDLES, TO AVOIDDAMAGING CRITICAL STRUCTURES, SOFT TISSUE AND/OR HAND GLOVES AVOID EXCESSIVE FORCE WHEN TIGHTENING IMPLANT. DO NOT USE FORCEPS TO TIGHTEN IMPLANT. DAMAGE RESULTING FROM EXCESSIVE FORCE OR FORCEPS MAY CAUSE IMPLANT FAILURE. A DIMENSIONAL INSPECTION AND FUNCTIONAL TEST FOR THE STERNAL ZIPFIX CABLE TIE W/NEEDLE PEEK 2 WERE NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION AND THE PRODUCT REMAINS IN THE ORIGINAL SEALED PACKAGE. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE STERNAL ZIPFIX CABLE TIE W/NEEDLE PEEK 2 WAS FOUND TO HAVE NO DAMAGE OR DEFECTS AND THE INVOLVED PRODUCT WAS NOT RECEIVED FOR EVALUATION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED WITH THE EVIDENCE PROVIDED AND THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 08.501.001.20S, LOT NUMBER: 8764P24, THE PRODUCT WAS RELEASED ON: 02 MAY 2024, MANUFACTURING SITE: THIS IS PURCHASED ITEM, RECEIVED FROM 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

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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT A ZIPFIX BAND OPENED AFTER BEING TIGHTENED BY THE SURGEON. THIS BAND WAS USED. TWO OTHER BANDS FROM SAME BATCH WERE BROKEN.