BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI GAMMA3 Ø10.5X80MM

    MDR report key: 3223480 · Received July 12, 2013

    Report

    Report Number
    0009610622-2013-00376
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED EVENT WAS CONFIRMED. FUNCTIONAL TESTS PERFORMED REVEALED FUNCTION OF THE LAG SCREW BEING AS INTENDED. THE FUNCTION OF THE LAG SCREW RELATING THE FLUTES FOR THE U-BLADE WAS RESTRICTED DUE TO THE MATERIAL DISPLACEMENT FOUND AT THE THREAD. THE EVENT DESCRIPTION AS WELL AS DEVICE INSPECTION (SIGNIFICANT DRILL MARKS AT THE OUTER SURFACE OF THE NAIL DUE TO CONSIDERABLE MISDRILLING AND MATERIAL DISPLACEMENT AT THE THREAD OF THE LAG SCREW) AND FUNCTIONAL TESTS INDICATE, THAT THE ROOT CAUSE OF THE REPORTED EVENT IS NOT LINKED TO ANY DEFICIENCY OF THE DEVICES, BUT IS RATHER RELATED TO ROUGH HANDLING.

    Description of Event or Problem · 1

    DURING G3 LONG NAIL SURGERY, THE SURGEON TRIED TO INSERT THE U-LAG SCREW. THE SURGEON TRIED INSERTION OF GUIDE PIN SEVERAL TIMES, REDUCING FRACTURE PART. NEXT, DRILLING WAS DIFFICULT ALTHOUGH THE STEP DRILL WAS USED. AFTER INSERTING THE U-LAG SCREW, ALTHOUGH HE IS GOING TO INSERT U-BLADE, U-BLADE WAS NOT ABLE TO BE INSERTED. WHEN THE SURGEON CHECKED X-RAY IMAGE, IT TURNED OUT THAT THE LAG SCREW IS NOT INSERTED IN SCREW HOLE OF THE NAIL. THEREFORE, THE SURGEON REMOVED THE NAIL AND LAG SCREW. THE SURGEON CHANGED THE NAIL AND LAG SCREW TO A NEW DEVICE.

    Description of Event or Problem · 1

    DURING G3 LONG NAIL SURGERY, THE SURGEON TRIED TO INSERT THE U-LAG SCREW. THE SURGEON TRIED INSERTION OF GUIDE PIN SEVERAL TIMES, REDUCING FRACTURE PART. NEXT, DRILLING WAS DIFFICULT ALTHOUGH THE STEP DRILL WAS USED. AFTER INSERTING THE U-LAG SCREW, ALTHOUGH HE IS GOING TO INSERT U-BLADE, U-BLADE WAS NOT ABLE TO BE INSERTED. WHEN THE SURGEON CHECKED X-RAY IMAGE, IT TURNED OUT THAT THE LAG SCREW IS NOT INSERTED IN SCREW HOLE OF THE NAIL. THEREFORE, THE SURGEON REMOVED THE NAIL AND LAG SCREW. THE SURGEON CHANGED THE NAIL AND LAG SCREW TO A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321614 U-BLADE SET, TI GAMMA3 Ø10.5X80MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K152726

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other