BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPROTTE® NRFIT® KIT

    MDR report key: 23725456 · Received December 5, 2025

    Report

    Report Number
    9611612-2025-00050
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    June 16, 2025
    Report Date
    December 5, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    UDI-DI
    04048223127841
    PMA / PMN Number
    K160295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURRED IN UK. ATTEMPTED SPINAL ANAESTHESIA FOR MAJOR ROBOTIC UROLOGY SURGERY. UPON REMOVAL OF THE NEEDLE AND THE INTRODUCER TOGETHER TO ATTEMPT A FINAL TIME WITH A LONGER 25G NEEDLE, I NOTICED THAT THE PART OF THE SPINAL NEEDLE WAS RETAINED. THE NEEDLE BROKE AT THE LEVEL OF THE INTRODUCER WITH THE TIP RETAINED IN THE SUBCUTANEOUS TISSUE. NO RESISTANCE OR DIFFICULTY IN REMOVING OR INSERTING THE NEEDLE. I JUST HIT THE BONE A FEW TIMES DURING THE ATTEMPTS. NEEDLE VISUALISED WITH US. EXPLAINED TO THE PATIENT THAT WE WOULD NEED TO SURGICALLY REMOVE THE NEEDLE. SHE UNDERSTOOD THE SITUATION AND AGREED TO PROCEED. DECIDED TO PUT HER UNDER GENERAL ANAESTHESIA TO PERFORM XRAY AND PROCEED WITH THE REMOVAL. SHE AGREED TO CONTINUE WITH PLANNED SURGERY IF REMOVAL UNCOMPLICATED. TOTAL LIDOCAINE 1% 20 MLS. SPINE SURGICAL TEAM ARRIVED. NEEDLE WAS IDENTIFIED WITH FLUOROSCOPY AND REMOVED. PATIENT WAS PRONED FOR THE PROCEDURE AND THE SURGICAL WOULD WAS OF ABOUT 1 INCH IN LENGTH. UNEVENTFUL PROCEDURE WITH NO IMMEDIATE COMPLICATION. THE NEEDLE WAS FOUND AT THE LEVEL OF L2 CLOSE TO THE SPINOUS PROCESS, FAR FROM THE SPINAL CANAL. AFTER THE NEEDLE WAS REMOVED WE PROCEED WITH THE PLANNED SURGERY. NO FOLLOW UP OR SPECIAL REQUESTS BY THE SPINE SURGEONS, REABSORBABLE SUTURES IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857160 SPROTTE® NRFIT® KIT SPROTTE® NRFIT® KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 1567 04048223127841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other