SYNMESH CUTTER

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. ADDITIONAL NARRATIVE: H3, H6: PART: 397.091. LOT: A7BB15. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 25 APRIL 2018. EXPIRATION DATE: NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 REVEALED THAT THE SPRING OF THE SYNMESH CUTTER SST WAS BROKEN, THE FRAGMENT WAS RETURNED FOR INVESTIGATION. IN ADDITION, THE ETCHED INFORMATION IS FADED AND FOREIGN SUBSTANCE THAT APPEAR TO BE DRY WATER DROPS ON THE SURFACE AND ETCHED INFORMATION WERE FOUND. A DIMENSIONAL INSPECTION FOR THE SYNMESH CUTTER SST WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OBSERVED BROKEN CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. THE OBSERVED DISCOLORED/FADING CONDITION WAS IDENTIFIED AS AN END OF LIFE INDICATOR; DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. FOREIGN SUBSTANCE: THE POTENTIAL CAUSE IS BEING ATTRIBUTED TO CLEANING/STERILIZATION METHODS. DURING CLEANING, ONLY USE CLEANING AGENTS THAT ARE LABELLED FOR USE ON MEDICAL DEVICES AND IN ACCORDANCE WITH THE MANUFACTURER¿S INSTRUCTIONS (E.G. TEMPERATURE, CONTACT TIME, AND RINSE TIME). CLEANING AGENTS WITH A USED DILUTION PH OF WITHIN 7¿9.5 ARE RECOMMENDED. HIGHLY ALKALINE CONDITIONS (PH >11) CAN DAMAGE COMPONENTS/DEVICES, SUCH AS ALUMINUM MATERIALS. DO NOT USE SALINE, ENVIRONMENTAL DISINFECTION (INCLUDING CHLORINE SOLUTIONS) OR SURGICAL ANTISEPTICS (SUCH AS IODINE- OR CHLORHEXIDINE-CONTAINING PRODUCTS). DO NOT USE A CLEANING AID THAT CAN DAMAGE THE SURFACE OF INSTRUMENTS SUCH AS STEEL WOOL, ABRASIVE CLEANERS OR WIRE BRUSHES. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SYNMESH CUTTER SST 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. THE FOLLOWING SOURCE CONTROLLED DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: SYNMESH CUTTER.

Description of Event or Problem

MESH CUTTER SPRING BROKE WITHOUT BEING FORCED. THERE WAS NO DAMAGE OR INJURY REPORTED BY THE PATIENT OR USER. THERE WAS NO SIGNIFICANT DELAY.