BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, T7, DIAM. 2.7X16MM

    MDR report key: 5183298 · Received October 28, 2015

    Report

    Report Number
    0008010177-2015-00272
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 7, 2015
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K080667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON WAS IMPLANTING A VARIAX DISTAL RADIUS XXL 11 HOLE 145MM VOLAR DR PLATE ON WEDNESDAY (B)(6). DURING THE CASE 3 SCREWS BROKE WHILE TRYING TO TIGHTEN DOWN THE SCREW TO THE PLATE. THE PLATE (STERILE PACKED XXL VOLAR DR 11 HOLE 145MM) DID NOT BREAK, THAT STAYED IN THE PATIENT. THE BROKEN SCREWS BROKE OFF JUST UNDER THE HEAD. THE SCREWS DISTALLY WENT IN FINE AND EVERYTHING LOOKED PERFECT. WHEN WE WENT PROXIMAL IS WHEN WE ENCOUNTERED THE PROBLEM. THE SCREW STARTED OFF FINE AND THEN WHEN THE SCREW WAS GETTING CLOSE TO ENGAGING THE PLATE THERE WAS RESISTANCE AND THEN THE SCREW WOULD BREAK. WE WERE ABLE TO GET A FEW SCREWS IN AND IT WAS DETERMINED THAT WE HAD THE PLATE SECURELY LOCKED DOWN TO THE BONE SO THE DOCTOR WAS FINE WITH THE OUTCOME. THIS WAS A PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713412 BONE SCREW, T7, DIAM. 2.7X16MM PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other