BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02878

    MDR report key: 3132705 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02878
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6) 2013 FOR A DISTAL HUMERUS FRACTURE, THE SURGEON NOTED THAT TWO 2.7MM VARIABLE ANGLE LOCKING SCREWS WOULD NOT PURCHASE. THIS OCCURRED WHILE THE SURGEON WAS IMPLANTING A 3-HOLE VARIABLE ANGLE POSTERIOR LATERAL PLATE. THE SURGEON REVISED THE PATIENT WITH A 4-HOLE LATERAL PLATE AND SCREWS. THE SURGEON ATTEMPTED TO IMPLANT A MEDIAL DISTAL HUMERUS PLATE ON THE OTHER SIDE OF THE BONE. THE DRILL BIT BROKE. X-RAY SHOWED A SMALL FRAGMENT OF THE FLUTED END OF THE DRILL BIT LEFT IN THE DISTAL PORTION OF THE HUMERUS BONE. THE SURGEON CHOSE NOT TO REMOVE THE FRAGMENT. AN ADDITIONAL THIRTY MINUTES WAS ADDED TO THE SURGERY AS A RESULT OF THIS EVENT. THIS REPORT IS FOR A 3-HOLE VARIABLE ANGLE POSTERIOR LATERAL PLATE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236732 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention