(B)(4). INVESTIGATION: VIGILANCE INVESTIGATION CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. BOTH CARBIDE INLAYS ARE NOT IN PLACE, ONLY ONE HAS BEEN PROVIDED. THE PROVIDED CARBIDE INLAY IS MATCHING WITH THE JAW PART "A". THE SURFACE OF JAW PART "A" IS EVEN AND WITHOUT DEVIATION, WHILE AT PART "B" SEVERAL SMALL PRESSURE MARKS CAN BE FOUND. THESE PRESSURE MARKS WERE MOST LIKELY CAUSED DURING USING A NEEDLE, AFTER THE INLAY HAD ALREADY FALLEN OFF. IT IS NOT POSSIBLE TO DETERMINE WHEN THE INLAY HAS FALLEN OFF. AT THE SURFACES OF THE JAW, NO SOLDER RESIDES CAN BE FOUND. THEREFORE, WE ASSUME THAT THE SOLDER JOINT WAS NOT MANUFACTURED ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO OTHER SIMILAR COMPLAINT ARE LISTED, THEREFORE WE ASSUME AN INDIVIDUAL ISSUE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORD HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO A MANUFACTURING ERROR. CORRECTIVE ACTION: NO OTHER SIMILAR COMPLAINT, THEREFORE WE ASSUME AN INDIVIDUAL ISSUE. THE Q-COORDINATOR OF THE PRODUCTION PLANT WILL BE INFORMED AD REQUESTED TO INITIATE CORRECTIVE MEASURES.
D
Patient 1
IT WAS REPORTED THE JAW INSERT CAME LOOSE AND REMAINED IN SITU. THE REPORTER INDICATED THAT BOTH CARBIDE INSERTS OF THE NEEDLE HOLDER BECAME LOOSE DURING SURGERY AND FELL OFF. ONE CARBIDE INSERT WAS RETRIEVED THE OTHER ONE WASN?T FOUND. THEREFORE THERE IS A POSSIBILITY THAT IT REMAINED IN SITU. DURING CARDIAC SURGERY AFTER THE FIRST STITCH, THE NEEDLE HOLDER WAS OPENED AND THE SURGEON RECOGNIZED A PART THAT HAD FALLEN INTO THE PATIENT. THE PART COULD BE RETRIEVED IMMEDIATELY AND WAS 1MM WIDE AND 5MM LONG. IT ALSO SHOWED THAT THE INSERTS WERE MISSING ON BOTH SIDES OF THE NEEDLE HOLDER JAW. THE ENTIRE IN SITU WAS EXAMINED AFTER THE SECOND INSERT. IN ORDER TO EXCLUDE ANYTHING REMAINED IN THE VESSEL, AN ARTERIAL FLUSHING WITH SALINE SOLUTION WAS PERFORMED. SEVERAL X-RAYS WERE TAKEN TO FURTHER EXCLUDE THE FOREIGN BODY FROM REMAINING IN SITU. NO FOREIGN BODIES WERE DETECTED, HOWEVER, SINCE THE BROKEN PART WAS STILL NOT FOUND, A POTENTIAL RETENTION OF THE PART IN THE PATIENT CANNOT BE COMPLETELY EXCLUDED.