STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SURGERY, IT WAS NOTED THAT THE ZIPFIX WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY.

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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: H3, H6 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE NEEDLE AND THE LOCKING HEAD WERE NOT ATTACHED TO THE DEVICE, NEITHER RETURNED FOR ANALYSIS. THE SURFACE OF THE CABLE TIE SHOWS EVIDENCE OF BREAKAGE, THEREFORE, THE REPORTED CONDITION CAN BE CONFIRMED. ADDITIONALLY, SCRATCHES WERE OBSERVED OVER THE BACK SURFACE OF THE TOOTHED AREA. THE OBSERVED CONDITION OF THE DEVICE CAN BE CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. SURGICAL TECHNIQUE WAS REVIEWED AND THE FOLLOWING RELEVANT STATEMENT WAS FOUND AT PAGE 8 AND 10: PRECAUTIONS: DO NOT CUT THE IMPLANT DIRECTLY AT THE NOTCH. REMOVING THE NEEDLE BY BENDING OR TWISTING WILL CAUSE A DEFORMED END THAT MAY DAMAGE THE LOCKING HEAD DURING INSERTION. ALWAYS ENSURE THAT THE IMPLANT END IS CUT AND NOT DEFORMED. IF THE IMPLANT IS NOT CUT, IMPLANT FAILURE MAY OCCUR. PRECAUTIONS: TO AVOID DAMAGE TO THE LOCKING HEAD: STAINLESS STEEL NEEDLES MUST BE REMOVED BEFORE CLOSING THE ZIPFIX IMPLANT. PRIOR TO INSERTION OF THE CUT END, ENSURE THE ZIPFIX IMPLANT IS PROPERLY ORIENTED SUCH THAT THE TOOTHED SURFACE CONTACTS THE STERNUM. ALIGN THE CUT END WITH THE LOCKING HEAD DURING INSERTION. DO NOT INSERT AT AN ANGLE. AVOID EXCESSIVE FORCE WHEN TIGHTENING IMPLANT. DO NOT USE FORCEPS TO TIGHTEN IMPLANT. DAMAGE RESULTING FROM EXCESSIVE FORCE OR FORCEPS MAY CAUSE IMPLANT FAILURE. ENSURE THAT THE IMPLANT BODY IS NOT TWISTED WHILE PASSING THE CUT END THROUGH THE LOCKING HEAD. ZIPFIX IMPLANT SHOULD ONLY BE INSERTED ONCE INTO THE LOCKING HEAD. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE STERNAL ZIPFIX CABLE TIE W/NEEDLE PEEK 2 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, 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 REVIEW (DHR): A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 08.501.001.20S LOT NUMBER: 3427P14 IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 04 APR 2023 MANUFACTURING SITE: THIS IS A PURCHASED ITEM, DELIVERED BY SAMAPLAST, SHIPPED BY JABIL BETTLACH. EXPIRY DATE: 01 FEB 2028.