BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, T7, DIAM. 2.7X14MM

    MDR report key: 3191462 · Received June 26, 2013

    Report

    Report Number
    0008010177-2013-00133
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K080667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, A METALLURGICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED.AS PER STATISTICAL EVALUATION NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. DEVICE DISCARDED.

    Description of Event or Problem · 1

    DURING A ROUTINE DISTAL RADIUS FRACTURE THE 2.7MM VARIAX DISTAL RADIUS TORQUE HEAD SCREW BROKE UPON FINAL TIGHTENING. THE PROPER DRILL BIT WAS USED PRIOR TO INSERTING THE SCREW. THE BROKEN SCREW WAS LEFT IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290000 BONE SCREW, T7, DIAM. 2.7X14MM IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG NA

    Patients

    Seq Age Sex Outcome Treatment
    1