BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW, TI GAMMA3® Ø8X17.5MM

    MDR report key: 3948710 · Received July 22, 2014

    Report

    Report Number
    0009610622-2014-00360
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SET SCREW FROM TROCHANTERIC NAIL KIT (LOT CODE K0A6BB4) WAS RETURNED FOR INVESTIGATION AND SHOWS TYPICAL TRACES OF OBLIQUE INSERTION. THE SET SCREW (K903493) IS ONLY LISTED IS THE INQUIRY BUT NOT ASSOCIATED TO THE EVENT. INVESTIGATION REVEALED THE SUBJECT PRODUCT TO BE A CONCOMITANT ITEM RESPECTIVELY BEING LISTED IN THE INQUIRY. THE DEVICE DID NOT CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING G3 NAIL SURGERY, WHEN THE SURGEON INSERTED THE SET SCREW, THE SET SCREW WAS STUCK INSIDE THE NAIL. THE LAG SCREW WAS NOT ABLE TO BE LOCKED. THEREFORE THE SURGEON REMOVED THE LAG SCREW AND NAIL. THE SURGEON THOUGHT THAT THE THREAD INSIDE NAIL WAS DAMAGED. THE SURGEON OPENED ANOTHER NAIL AND INSERTED SET SCREW FIRST USED TO THE NAIL. HOWEVER THE SET SCREW WAS STUCK INSIDE THE NAIL. AFTERWARDS, BECAUSE THE SET SCREW OPENED TO THE 2ND WAS INSERTED IN NAIL USED FIRST, THEY WERE USED AND THE OPERATION WAS FINISHED.

    Description of Event or Problem · 1

    DURING G3 NAIL SURGERY, WHEN THE SURGEON INSERTED THE SET SCREW, THE SET SCREW WAS STUCK INSIDE THE NAIL. THE LAG SCREW WAS NOT ABLE TO BE LOCKED. THEREFORE THE SURGEON REMOVED THE LAG SCREW AND NAIL. THE SURGEON THOUGHT THAT THE THREAD INSIDE NAIL WAS DAMAGED. THE SURGEON OPENED ANOTHER NAIL AND INSERTED SET SCREW FIRST USED TO THE NAIL. HOWEVER THE SET SCREW WAS STUCK INSIDE THE NAIL. AFTERWARDS, BECAUSE THE SET SCREW OPENED TO THE 2ND WAS INSERTED IN NAIL USED FIRST, THEY WERE USED AND THE OPERATION WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427176 SET SCREW, TI GAMMA3® Ø8X17.5MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K903493

    Patients

    Seq Age Sex Outcome Treatment
    1 Other