BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/20MM

    MDR report key: 2875004 · Received December 17, 2012

    Report

    Report Number
    8030965-2012-01597
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. SLIGHT DEFORMATIONS VISIBLE AT THE SCREW HEAD. THE RELEVANT DIMENSIONS AT THE SCREW HEAD WERE CHECKED AND IT WAS FOUND THAT THEY ARE NOT ACCORDING TO THE SPECIFICATION. WE ASSUME THAT THIS DEVIATION IS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    DURING A TI STERNAL LOCKING PLATE PROCEDURE, THE SURGEON WAS INSERTING ONE OF THE 20 MM SELF DRILLING LOCKING SCREWS. AS THE SURGEON EXERTED PRESSURE TO LOCK THE SCREW INTO THE PLATE, THE SCREW HEAD WENT THROUGH THE PLATE HOLE AND DID NOT LOCK INTO THE PLATE. THE SURGEON REMOVED THE SCREW. HE REPLACED IT WITH ANOTHER SCREW AND INSERTED IT INTO A DIFFERENT SCREW HOLE AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/20MM STERNAL LCKNG SCREW HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCREW, PLATE