BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3X14MM KNOCHENSCHR, CROSS-PIN, SELBST-S

    MDR report key: 2150591 · Received June 22, 2011

    Report

    Report Number
    8010177-2011-00177
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K062498
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHILE TRYING TO REMOVE BONE SCREW FROM PATIENT'S FINGER, SCREW HEAD STRIPPED FROM IMPLANTATION. DOCTOR TRIED SCREWDRIVER AND WAS UNABLE TO GET SCREW BACK OUT. WORKED AWAY SOME BONE WITH GRASPING TOOLS AND BROKE OFF HEAD OF SCREW. DOCTOR FELT AS THOUGH TITANIUM MATERIAL OF SCREW WAS THE ISSUE. BROUGHT INTO SURGERY EXTRACTION SYSTEM FOR SCREW REMOVAL BUT DOCTOR SAID SMALLEST CROWN DRILL WAS TOO LARGE AND WAS AFRAID OF FRACTURE. WORKED AT SCREW UNTIL THE LEFT OVER PORTION WAS BELOW THE BONE CORTEX AND LEFT BROKEN PORTION IN THE FINGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.3X14MM KNOCHENSCHR, CROSS-PIN, SELBST-S IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK