BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROSET ORTHO 5CC

    MDR report key: 1640969 · Received February 5, 2010

    Report

    Report Number
    8010177-2009-00251
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 7/1/2006 TO 7/1/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED (B)(4). THERE ARE 4 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED) AND PRODUCT CODE (MQV).

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. IT WAS REPORTED THAT, HYDROSET WAS INJECTED INTO THE FRACTURE SITE ON A DISTAL RADIUS. THE DOCTOR WANTED TO PUT A SCREW THROUGH THE HYDROSET, BUT THE PRODUCT NEVER SET UP, OR GOT HARD ENOUGH TO PUT A SCREW INTO. WE WAITED ABOUT 30 MINUTES AND STILL THE PRODUCT WAS NOT HARD. THE DOCTOR THEN DECIDED TO SCOOP OUT SOME OF THE HYDROSET AND SECURED THE PLATE THROUGH ANOTHER HOLE. THE SYRINGE TECHNIQUE WAS USED. TEMPERATURE IN THE OPERATING ROOM WAS NORMAL AT AROUND 68F TO 69F. NO NOTABLE STORAGE CONDITIONS PRIOR TO SURGERY WERE PRESENT. NO POWER WAS LOST DURING MIXING OF THE PRODUCT. NO AGGRESSIVE SALINE WAS ADDED. BLOOD FLOW TO THE IMPLANT SIGHT WAS NO MORE THAN NORMAL. THE IFU WAS FOLLOWED PROPERLY. IT WAS HOWEVER, THE SURGEON'S FIRST EXPERIENCE EVER USING HYDROSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROSET ORTHO 5CC IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other