BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADWELL

    MDR report key: 24752006 · Received April 1, 2026

    Report

    Report Number
    9710376-2026-00002
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 27, 2026
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08720791376604
    PMA / PMN Number
    K130136
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TECHNOMED RECEIVED COMPLAINT VIA DISTRIBUTOR CADWELL 10 MARCH 2026 WITH REGARDS TO THE SUBDERMAL NEEDLE PART NUMBER: 302875-000 (NEEDLE, PARALLEL,14X0.38MM (27G) 100IN12PR), EITHER LOT: 103210: THE COMPLAINT IS THAT THE NEEDLE BROKE OFF IN THE PATIENT, REQUIRING AN ADDITIONAL PROCEDURE TO REMOVE IT. THE EVENT DATE WAS TODAY, MARCH 10TH. "WHILE REMOVING NEEDLES AT THE END OF THE CASE, I NOTICED ONE SHARP HAD BROKEN OFF ABOVE THE HUB FROM THE LEFT VL MUSCLE. I CHECKED THE TAPE AND SURROUNDING AREA BUT COULD NOT FIND THE SHARP. I IMMEDIATELY NOTIFIED THE RN AND RESIDENT WHO WAS STILL IN THE ROOM. WE BOTH FELT AROUND THE INSERTION AREA (WHICH ALSO SHOWED TWO BURN MARKS); NEITHER OF US COULD FEEL THE NEEDLE AND WE WERE NOT CERTAIN IT WAS IN THERE. I SUGGESTED WE ASK (B)(6) TO COME BACK IN THE ROOM TO CONFIRM THE SHARP WAS NO LONGER IN THE PATIENT. THE RESIDENT AGREED. FLAT PLATE IMAGES WERE TAKEN AND THE BROKEN SHARP WAS LOCATED. DR. (B)(6) CAME BACK INTO THE OPERATING ROOM AND PERFORMED ANOTHER PROCEDURE TO REMOVED THE SHARP. THIS ENDED UP IN AN ADDITIONAL HOUR OF OPERATING ROOM TIME, ADDITIONAL (B)(6) TIME, ADDITIONAL LOCAL ANESTHETIC, SILVER NITRATE MATCHSTICKS FOR HEMOSTASIS AND TWO 2.0 MONOCRYLS. " THE EVENT OCCURED DURING THE FOLLOWING PROCEDURE: T10-PELVIS POSTERIOR FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491096 CADWELL DISPOSABLE SUBDERMAL NEEDLE ELECTRODE GXZ TECHNOMED EUROPE 302875-000 103210 08720791376604

    Patients

    Seq Age Sex Outcome Treatment
    1