BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW, CROSS-PIN, DIAM.2.3X16MM, STERILE, (1/PACKAGE)

    MDR report key: 3191464 · Received June 26, 2013

    Report

    Report Number
    0008010177-2013-00132
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF INTRAOPERATIVE SCREW FRACTURE BY REMOVAL COULD BE PARTIALLY CONFIRMED, BECAUSE THE SCREW BROKE DURING APPLICATION. THE INVESTIGATION RESULTS SHOWED THAT TOO HIGH BENDING FORCES ACTED ON THE PLATE DURING APPLICATION. THESE BENDING FORCES LED TO HIGH TRACTION FORCES BEING APPLIED TO THE SCREW HEAD AND CAUSED THE BREAKAGE OF TWO WINGS. THE FRACTURED SURFACE HAD THE APPEARANCE OF A FORCED RUPTURE CAUSED BY HIGH TRACTION FORCES. NO INDICATIONS WERE FOUND FOR MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REVISION SURGERY WAS PERFORMED WITH THE RECONSTRUCTION PLATE. AFTER THAT THE PLATE WAS BROKEN AND THE REVISION SURGERY WAS PERFORMED AGAIN ON (B)(6) 2013. DURING THE SURGERY, WHEN SURGEON TRIED TO EXTRACT THE SCREWS, HEAD OF 2 SCREWS BROKE.

    Description of Event or Problem · 1

    ON 2013 (B)(6), THE REVISION SURGERY WAS PERFORMED WITH THE RECONSTRUCTION PLATE. AFTER THAT THE PLATE WAS BROKEN AND THE REVISION SURGERY WAS PERFORMED AGAIN ON 2013 (B)(6). DURING THE SURGERY, WHEN SURGEON TRIED TO EXTRACT THE SCREWS, HEAD OF 2 SCREWS BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291274 BONE SCREW, CROSS-PIN, DIAM.2.3X16MM, STERILE, (1/PACKAGE) IMPLANT JEY STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1