RIGIDFIX FEM 3.3MM S/T XPIN

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE SLEEVE AND TROCAR WERE RETURNED TOGETHER AS PART OF THE SAME KIT. UPON VISUAL INSPECTION, THE SLEEVE AND THE TROCAR WERE FOUND JAMMED, IT COULD BE OBSERVED STRETCH MARKS ALL OVER THE SLEEVE, ALSO ON THE TROCAR. 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 RIGIDFIX FEM 3.3MM S/T XPIN WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE.¿ BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE FOR THE JAMMED CONDITION CAN BE ATTRIBUTED TO CONSIDERING THAT THE SLEEVE AND THE TROCAR HAS THE STRETCH MARKS, WE CAN RELATE THIS ISSUE TO A BAD AXIS ALIGNMENT OF THE DRILL AT THE MOMENT OF INSERTION, THE BENDING FORCE APPLIED AND THE HIGHER SPINNING SPEED OF THE DRILL CAN CONTRIBUTE TO THE JAMMING CONDITION OF THE SLEEVE AND THE TROCAR. AS PER IFU: DIRECTIONS FOR A SUCCESSFULLY HOLE DRILLING AND TROCAR AND SLEEVE INTERACTION ARE PROVIDED. 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 DEPUY SYNTHES 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 DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE WAS JAMMED/SEIZED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A MATCH ISSUE. THE DISPOSABLE DRILL AND SLEEVE DID NOT FIT AND COULD NOT BE USED DURING A SURGICAL PROCEDURE. THE LEFT SIDE WAS THE AFFECTED SIDE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.