BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK PRODUCT - TARGET DEVICE

    MDR report key: 1861327 · Received October 4, 2010

    Report

    Report Number
    9610622-2010-00428
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING GAMMA NAIL SURGERY, IT WAS NOTICED THAT THE SURGEON WAS NOT USING THE JIG CORRECTLY AND KEPT UNSCREWING THE END KNOB WHEN WANTING TO OPEN AND CLOSE THE TARGET HOLES. I POINTED THIS OUT POLITELY WITH SLIGHT ACKNOWLEDGEMENT. THE CASE WENT WELL UNTIL THE SURGEON PERFORMED DISTAL LOCKING, WHERE HE NOTICED THE SCREWDRIVER WAS HARD TO DISENGAGE FROM THE SCREW HEAD. AP SHOTS WERE TAKEN WHICH LOOKED FINE, AND SURGEON DISENGAGED THE JIG FROM NAIL SO HE COULD PUT IN AN END CAP. DURING THIS TIME, HE ASKED FOR A MEDIAL LATERAL SHOT, AND THAT WAS WHEN HE REALIZED THE DISTAL SCREW MISSED THE NAIL AND WAS PLACED POSTERIOR TO THE IMPLANTED NAIL. THE SURGEON DID REMEMBER TO RETIGHTEN THE NAIL HOLDING BOLT BEFORE COMPLETING THE DISTAL LOCKING AND IN PARTICULAR AFTER TAPPING THE STRIKE PLATE TO PERSUADE THE NAIL DISTALLY INTO THE FEMUR. I AM UNSURE IF THE KNOB ON THE END OF THE JIG WAS TIGHTENED TO HOLD THE TISSUE SLEEVES WHEN HE DID THE DISTAL LOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PRODUCT - TARGET DEVICE INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other