JAMSHIDI BONE MARROW TRAY 11G X4

Additional Manufacturer Narrative

(B)(4). TWO SAMPLES WERE PROVIDED FOR THE SAMPLE ANALYSIS. ONE SAMPLE WAS A BIOPSY CANNULA (NO STYLET) THAT WAS BROKEN APPROXIMATELY 2¿ ABOVE THE DISTAL END OF THE CANNULA. THE SECOND SAMPLE WAS A FULL BIOPSY NEEDLE ASSEMBLY (BOTH STYLET AND CANNULA) AND DID NOT APPEAR TO BE USED. VISUAL INSPECTION OF THE BROKEN PORTION OF THE CANNULA NOTED A BEND IN THE CANNULA JUST ABOVE THE BROKEN EDGE OF THE CANNULA AND ALSO NOTED THE END OF THE CANNULA OF DEFORMED AND JAGGED SUGGESTING THE NEEDLE WAS BROKEN DURING USE. THE MOST LIKELY SOURCE OF THIS TYPE OF DAMAGE TO A BIOPSY CANNULA WOULD BE THROUGH THE APPLICATION OF A LATERAL FORCE ON THE BIOPSY CANNULA DURING THE REMOVAL PROCESS CAUSING THE NEEDLE CANNULA TO BEND AND ULTIMATELY BREAK. THE INVESTIGATION WAS NOT ABLE TO DEFINITIVELY CONFIRM THIS FAILURE MODE SINCE THE ACTUAL CONDITIONS OF THE PROCEDURE AND ACTIONS OF THE USER WAS NOT KNOWN FOR THIS INVESTIGATION. A REVIEW OF THE DHR AND STERILIZATION RECORDS DID NOT IDENTIFY AND ISSUES RELATED TO THIS FAILURE MODE DURING THE TIME OF THE REPORTED COMPLAINT. THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED FAILURE MODE WAS IDENTIFIED AS AN APPLICATION OF A LATERAL FORCE BY THE END USER DURING THE PLACEMENT OR REMOVAL PROCESS OF THE BIOPSY CANNULA. THE APPLICABLE CAUTION WAS NOTED IN THE DIRECTIONS OF USE FOR THE BIOPSY NEEDLE. BASED ON THE IDENTIFIED PROBABLE ROOT CAUSE, THE CUSTOMER WILL BE MADE AWARE OF THE CAUTION PROVIDED IN THE APPLICABLE DIRECTIONS OF USE FOR THIS BIOPSY NEEDLE.

Additional Manufacturer Narrative

(B)(4). UPON (B)(4) INVESTIGATION A FOLLOW UP EMDR WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

BIT WAS REPORTED THAT THE NEEDLE BROKE OFF INSIDE THE PATIENT WHEN ATTEMPTING TO GET A SAMPLE. WHEN THE NEEDLE WAS PULLED OFF ABOUT AN INCH AND A HALF WAS LEFT INSIDE THE PATIENT. IT IS BELIEVED THAT THE NEEDLE IS STILL INSIDE THE PATIENT'S ILIAC CREST. PT IS (B)(6). STABLE PATIENT WITH HISTORY OF MULTIPLE MYELOMA. NO EVIDENCE OF HEMORRHAGE OR INFECTION AT THE OPERATIVE SITE. MILD PAIN AT THE OPERATIVE SITE REPORTED. THE REMAINING SEGMENT OF NEEDLE COULD NOT BE EXTRACTED SURGICALLY. THE SURGEON HAS DETERMINED THAT THE NEEDLE IS VERY SECURELY IN PLACE AND EXPECTS THE RISK OF FURTHER COMPLICATIONS TO BE EXTREMELY LOW. THE PROCEDURE WAS ABORTED. THERE IS NO PLAN TO REPEAT THE PROCEDURE IN THE NEAR TERM. YES, THE INSERTION WAS VERY DIFFICULT, MOST LIKELY DUE TO SCLEROTIC BONE, EITHER SECONDARY TO THE DISEASE PROCESS OR TO PAST SAMPLING OF THIS REGION OF THE PATIENT'S RIGHT POSTERIOR ILIAC CREST. YES. THE PRESENCE OF REMAINING NEEDLE, VIRTUALLY ENTIRELY EMBEDDED WITHIN THE BONE, WAS DETECTED INTRAOPERATIVELY. THE SEGMENT OF REMAINING NEEDLE MEASURES APPROXIMATELY 1.0 - 1.5 INCHES. LAB HAS A COMPANION SAMPLE THAT WAS; FROM THE LAST PACKAGE WE HAD OF THIS LOT NUMBER. IT WAS USED AS A VISUAL MEASUREMENT, OF WHAT WAS STILL IN THE PATIENT. IT IS NO LONGER IN THE ORIGINAL PACKAGE BUT I HAVE THE ORIGINAL PACKAGING AND THIS NEEDLE IN A SEPARATE CONTAINER. I AM BEING TOLD THAT THE OTHER LABS IN OUR HEALTHCARE SYSTEM DO NOT HAVE THIS LOT NUMBER. A PHOTOGRAPH (NOT PROVIDED TO (B)(4)) OF THE BROKEN NEEDLE SHOWS THAT THE DISTAL END OF THE PORTION REMOVED IS ESSENTIALLY ROUND, RATHER THAN LINEAR, RAISING THE POSSIBILITY THAT ROTATIONAL FORCES PLAYED A MAJOR ROLE IN INSTRUMENT FAILURE. THAT WAS A COMMENT FROM THE PATHOLOGIST WHO PERFORMED THE BONE MARROW BIOPSY.