SPROTTE® NRFIT

Additional Manufacturer Narrative

RN# (B)(4) COMPLAINT TOOK PLACE IN UK. NOTE: LOT NUMBER COULD NOT BE TRANSMITTED TO PAJUNK AFTER SEVERAL REQUESTS TO THE CLINIC. THIS MEANS THAT NO MFR AND EXP DATE COULD BE TRANSFERABLE IN THE DOCUMENT. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

Description of Event or Problem

IRN# (B)(4) INCIDENT OCCURRED IN UK: PANJUNK SPROTTE 25X90MM NEEDLE BROKE WHILE PULLING OUT, HOWEVER ENTIRE NEEDLE COULD BE RETRIEVED.CONFIRMED BY -NOTING BEVEL AT DISTAL END, COMPARING LENGTH OF BROKEN PARTS WITH ANOTHER NEEDLE (90MM). REPORTER NOTES - "IDON'T THINK THERE WAS NOT ANY EXCESSIVE FORCE INVOLVED. JUST A ROUTINE SPINAL WITH MILD DIFFICULTY DUE TO HIGH BMI. THE NEEDLE BREAK IN SUCH CASE RAISES CONCERN. I DON'T THINK THINGS COULD HAVE BEEN DONE DIFFERENTLY FROM POINT OF VIEW OF TECHNIQUE, HUMAN FACTORS ETC" BMI 40+.