BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U-BLADE SET, TI GAMMA3® Ø10.5X80MM

    MDR report key: 9556103 · Received January 6, 2020

    Report

    Report Number
    0009610622-2020-00006
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    December 10, 2019
    Report Date
    March 5, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, AS THE DEVICE WAS RETURNED FOR EVALUATION AND X-RAYS WERE AVAILABLE TO CONFIRM THE ALLEGED FAILURE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RECEIVED LAG SCREW SHOWS SIGNS OF INTERACTION WITH NAIL WHICH IS EVIDENT BY APPEARANCE OF SCUFF MARKS ON THE OUTER SURFACE OF THE LAG SCREW. THIS CONFIRMS RELATIVE MOVEMENT AND CONSTANT RUBBING OF THE LAG SCREW WITH THE NAIL DURING THE CUT-OUT. HOWEVER, NOTICEABLY THERE ARE TWO INDENTATION MARKS CAUSED BY SET SCREW. THE ONE ON RATHER ONE-THIRD PART OF THE GROOVE FROM THE LATERAL SIDE IS THE INITIAL BEARING POINT OF THE SET SCREW. THE SECOND MARK OCCURRED WHEN THE SET SCREW MOVED FROM ITS INITIAL LOCATION LATERALLY TOWARDS THE NARROWER GROOVE AND ULTIMATELY GETTING CAUGHT. THE MOVEMENT IS MOST LIKELY TO HAVE BEEN CAUSED DUE TO EXTRA BIT OF LOOSENING OF THE SET SCREW (MORE THAN QUARTER OF A TURN) DONE BY THE SURGEON THAN IT IS REQUIRED AS PER THE OP-TECH. STILL THE IMPLANTATION WAS ACCEPTABLE AS THE LAG SCREW WAS NOT LET COMPLETELY LOOSE. A FUNCTIONAL INSPECTION WAS PERFORMED BY ASSEMBLING THE RETURNED U-BLADE LAG SCREW, NAIL AND SET SCREW TOGETHER. AS A RESULT, THE ASSEMBLY WAS SUCCESSFUL WITHOUT ANY ABNORMALITY. SEVERAL X-RAYS AND CTS WERE AVAILABLE AND PROVIDED TO OUR MEDICAL EXPERT. SINCE THOSE WERE NOT CLEAR ENOUGH, THE MEDICAL EXPERT COULDN¿T PROVIDE ANY CERTAIN ASSESSMENT BUT HOWEVER A SEVERE REDUCED BONE DENSITY IN THE PATIENT WAS ASSUMED BY HIM. EVALUATION OF THE POST OP AND POST CUT-OUT X-RAYS ALSO REVEALED THAT THERE WAS A SUBSTANTIAL ROTATION OF THE FEMORAL HEAD FROM ITS INITIAL POSITION. BASED ON THE X-RAY EVALUATION AND THE RETURNED DEVICES IT IS ASCERTAINED THAT THE CUT-OUT HAPPENED PARTICULARLY DUE TO ROTATION (MOVEMENT) OF THE FEMORAL HEAD INFERIORLY. THIS MOVEMENT LED TO CUTOUT OF THE LAG SCREW THROUGH THE FEMORAL HEAD DURING PATIENT¿S POST-OPERATIVE ACTIVITIES. HOWEVER, THE MAL-POSITIONING OF THE SET SCREW HAD NO CONSEQUENCE ON THE OCCURRENCE OF THE CUT-OUT, IT JUST LED TO A SLIGHT MEDIAL MOVEMENT OF THE LAG SCREW DURING THE CUT-OUT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON THE ABOVE INVESTIGATION, THE FAILURE IS ATTRIBUTED TO A PATIENT RELATED FACTOR, PREDOMINANTLY. IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED, BECAUSE THERE IS A GAMMA NAIL U RUG REMOVAL TECHNIQUE, WE PERFORMED A PRE-OPERATIVE DEMONSTRATION FOR DOCTORS. WHEN THE CASE WAS CONFIRMED THAT DAY, THE U LAG SCREW PENETRATED THE BONE HEAD. THE DOCTOR CONFIRMED THE X-RAYS BEFORE AND AFTER THE OPERATION, BUT THERE WERE NO SPECIAL PROBLEMS SUCH AS REDUCTION AND IMPLANT PLACEMENT. THE IMPLANT WAS RECOVERED AND REPLACED WITH THA.

    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

    IT WAS REPORTED, BECAUSE THERE IS A GAMMA NAIL U RUG REMOVAL TECHNIQUE, WE PERFORMED A PRE-OPERATIVE DEMONSTRATION FOR DOCTORS. WHEN THE CASE WAS CONFIRMED THAT DAY, THE U LAG SCREW PENETRATED THE BONE HEAD. THE DOCTOR CONFIRMED THE X-RAYS BEFORE AND AFTER THE OPERATION, BUT THERE WERE NO SPECIAL PROBLEMS SUCH AS REDUCTION AND IMPLANT PLACEMENT. THE IMPLANT WAS RECOVERED AND REPLACED WITH THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12607 U-BLADE SET, TI GAMMA3® Ø10.5X80MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K08369B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention