Additional Manufacturer Narrative · 1
INSTRUMENT WAS DISCARDED BY HOSP WHAT MADE EVALUATION OF DEVICE ITSELF IMPOSSIBLE. WE WERE INFORMED BY THE DISTRIBUTOR THAT DURING CORE BX OF LEFT ILIAC CREST USING FLUOROSCOPY AND SAPINE SYSTEM, A PORTION OF THE NEEDLE REFERRED TO AS THE "PIG TAIL" BROKE OFF IN THE PROCEDURE SITE AND WAS NOT ABLE TO BE RETRIEVED. NO PATIENT INJURY WAS REPORTED. SINCE NEITHER THE INSTRUMENT ITSELF WAS AVAILABLE TO US FOR EVALUATION, AS IT WAS DISCARDED BY THE HOSP NOR, IN CONSEQUENCE OF THIS, THE LOT NO. OF THE INSTRUMENT, WE WERE NOT IN A POSITION TO PERFORM ANY KIND OF INSPECTION OR TO CHECK THE RESPECTIVE PRODUCTION DOCUMENTS BUT COULD ONLY REFER TO OUR TREND ANALYSIS RECORDS FOR THIS ARTICLE. WE CHECKED THE TREND ANALYSIS RECORDS STARTING IN THE YEAR 1998. SINCE THEN WE HAVE SOLD A LOT OF THIS ARTICLE TO THE DISTRIBUTOR, WITHOUT RECEIVING ANY COMPLAINTS. CONCLUSION: SINCE NEITHER THE INSTRUMENT NOR THE LOT NUMBER WE WERE AVAILABLE FOR INVESTIGATION WE CANNOT DRAW ANY CONCLUSION AS TO THE EXACT CAUSE FOR THIS INCIDENT. OUR TREND ANALYSIS RECORDS SHOW NO DISCREPANCIES AS TO WHY WE ARE OF THE OPINION, THAT NO CORRECTIVE ACTION OR PREVENTIVE ACTION IS NECESSARY AT OUR END.