BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF-DRILLING HALF PIN APEX HA-COATED 5MM, 150 X

    MDR report key: 2243386 · Received August 26, 2011

    Report

    Report Number
    8031020-2011-00185
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 3, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JDW
    PMA / PMN Number
    K061493
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WITH SEVERE ARTHROSIS TO THE REAR FOOT AND ANKLE, END-STAGE POSTERIOR TIBIAL DYSFUNCTION, EQUINUS DEFORMITY, AND CHRONIC FOOT PAIN WITH SEVERE ANGULAR DEFORMITY UNDERWENT CORRECTION (TENDO-ACHILLES LENGTHENING TO THE RIGHT ANKLE, MODIFIED TRIPLE ARTHRODESIS TO THE FOOT AND ANKLE, MULTIPLE MIDFOOT FUSION TO THE FOOT AND ANKLE WITH APPLICATION OF EXTERNAL FIXATOR THE UTILIZED 'HA COATED SHANZ PINS'.) PATIENT RETURNED TO OPERATING ROOM AS A RESULT OF A BROKEN SCHANTZ PIN APPROXIMATELY TWO MONTHS LATER. THE SURGEON MANIPULATED THE MULTIPLANE EXTERNAL FIXATOR TO THE FOOT AND ANKLE AND REMOVED THE BROKEN PIN AND PLACED ADDITIONAL PINS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF-DRILLING HALF PIN APEX HA-COATED 5MM, 150 X IMPLANT JDW STRYKER OSTEOSYNTHESIS SELZACH NA W17066

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R