BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6X20MM CALAXO SCREW

    MDR report key: 800351 · Received December 21, 2006

    Report

    Report Number
    1219602-2006-00204
    Event Type
    Malfunction
    Date Received
    December 21, 2006
    Date of Event
    November 17, 2006
    Report Date
    December 21, 2006
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREWS RETURNED FOR EVALUATION WERE BROKEN IN NUMEROUS PIECES. WE RECOMMENDED IN HARD BONE, TO INCREASE THE TAP SIZE BY 1 MM WHICH WILL DECREASE INSERTION DIFFICULTY.

    Description of Event or Problem · 1

    THE SURGEON WAS DOING A DOUBLE BUNDLE ACL AND DUE TO THE FACT THAT HIS TUNNELS WERE SMALL, HE REQUESTED SIZE 6 AND 7 CALAXO SCREWS TO BE AVAILABLE. FOR TIBIAL FIXATION, HE WAS USING HAMSTRING GRAFT ON PATIENT AND FOR THE POSTERIOR MEDIAL BUNDLE, HE TAPPED USING A SIZE 6 TAP AND ATTEMPTED TO INSERT SIZE 7 INTERFERENCE SCREW AND IT BROKE IN A SPIRAL MANNER AND THEN HE ATTEMPTED A SECOND ONE, AS HE WAS CONCERNED THAT PERHAPS HE HAD NOT TAPPED FAR ENOUGH. THE SECOND ONE ALSO BROKE AND THEN LEFT A PIECE BEHIND IN THE TUNNEL. FOR THE ANTERIOR LATERAL TUNNEL, HE TAPPED FOR A SIZE 6 AND IT HAD HARDLY BEEN INSERTED WHEN IT BROKE TOO. THE SURGEON HAS EXTENSIVE EXPERIENCE WITH THE SURGERY AND NORMALLY USES BIORCIHA AND HAS DONE SINCE ITS LAUNCH. IT WAS HIS FIRST TIME USING THE CALAXO PRODUCT. THE SURGEON MANAGED TO RETRIEVE SOME OF IT, BUT SOME PIECES REMAINED IN THE TUNNELS. IT WAS CONFIRMED THAT THE PATIENT WAS A FEMALE WITH EXCEPTIONALLY HARD BONE AND THE SURGEON WAS USING THE GUIDEWIRE DESIGNED FOR CALAXO PART 7211138 AND THAT THE SCREWS WERE PROPERLY SEATED ON THE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6X20MM CALAXO SCREW CALAXO SCREW HWC SMITH & NEPHEW INC., ENDOSCOPY DIV. 7211109 50152330

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR