BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X10MM,(5/PACKAGE)

    MDR report key: 3183037 · Received June 21, 2013

    Report

    Report Number
    0008010177-2013-00127
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS SHOWED THAT THE SCREW BROKE AS A RESULT OF TOO HIGH TORSIONAL FORCES IN FORCED RUPTURE MODE DURING INSERTION. THE FRACTURED SURFACE SHOWED THE TYPICAL FLOW STRUCTURES OF A DUCTILE TORSIONAL BREAKAGE. THE ROOT CAUSE OF THE FAILURE COULD HAVE BEEN TOO SMALL DIAMETER OR TOO LOW DEEPNESS OF THE PILOT HOLE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    A RESIDENT WAS TWISTING THE SCREW INTO THE PATIENT'S SKULL AND THE TOP PART BROKE FROM THE REST OF THE SCREW. THEY WERE NOT ABLE TO REMOVE THE REST OF THE SCREW FROM THE PATIENT'S SKULL.

    Description of Event or Problem · 1

    A RESIDENT WAS TWISTING THE SCREW INTO THE PATIENT'S SKULL AND THE TOP PART BROKE FROM THE REST OF THE SCREW. THEY WERE NOT ABLE TO REMOVE THE REST OF THE SCREW FROM THE PATIENT'S SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283678 BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X10MM,(5/PACKAGE) IMPLANT JEY STRYKER OSTEOSYNTHESIS-FREIBURG 0

    Patients

    Seq Age Sex Outcome Treatment
    1