CABLE CUTTER W/TRIGGER HANDLE

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: PART NUMBER: 03.221.006 LOT NUMBER: T154445 PRODUCT CODE: N/A DATE OF MANUFACTURE: 22-FEB-2018 MANUFACTURING LOCATION: TUTTLINGEN PART EXPIRATION DATE: N/A NONCONFORMANCE NOTED: N/A DHR RECORD REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT 03.221.006, CABLE CUTTER W/TRIGGER HANDLE HAD SCREW BROKEN AND FELL APART UNATTACHED. THE OBSERVED CONDITION OF THE DEVICE CONSISTED WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CABLE CUTTER W/TRIGGER HANDLE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE COMPONENT FAILURE FOR BROKEN AND CAUSE CAN BE ESTABLISHED FOR FELL APART UNATTACHED, 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 COMPLAINT CONDITION. AS PART OF 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.

Description of Event or Problem

IT WAS REPORTED THAT THE CABLE CUTTER W/TRIGGER HANDLE CAME APART DURING A SURGICAL PROCEDURE. THE DEVICE BROKE INTO MULTIPLE PIECES INTRAOPERATIVELY WHILE BEING USED TO IMPLANT CABLES. THE BACKUP CABLE CUTTER WAS USED WITHOUT ISSUE, AND THE ORIGINAL DEVICE WAS RENDERED UNUSABLE AND REQUIRED REPLACEMENT. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT.