BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, T7, 2.7X20MM

    MDR report key: 3100445 · Received May 8, 2013

    Report

    Report Number
    0008010177-2013-00089
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K063875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. DURING INSERTION THE SCREW HAD CONTACT WITH A HARD OBJECT AND SO A FRAGMENT WAS CUT/COILED OFF. BECAUSE OF THE ABRASION MARKS ON THE FLANKS, NO FUNCTIONAL INSPECTION WAS POSSIBLE. ALL MEASURED DIMENSIONS APART FROM THE THREAD WERE WITHIN THE SPECIFIED VALUES. DURING INVESTIGATIONS NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 1

    THE SCREW IMPLANTED WAS TOO LONG AND THEREFORE HAD TO BE EXPLANTED AGAIN. THE NURSE NOTICED THAT THERE WAS A SORT OF STRING/FIBER ON THE SCREW TIP, AND AS SHE PULLED ON IT SHE HAD A METAL COIL EXTENDING THE ENTIRE LENGTH OF THE SCREW THREAD IN HER HAND. A DIFFERENT SCREW WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201861 BONE SCREW, T7, 2.7X20MM IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1