BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2823023 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02995
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PATIENT WAS BEING TREATED FOR A CLAVICLE DIAHYSEAL FRACTURE. THE SURGEON INSERTED A 2.7 LOCKING SCREW USING A DRIVER WITH TORQUE LIMITER. THE SURGEON DID NOT HEAR THE FINAL CLICK TIGHTENING THE SCREW AND WAS UNSURE IF THE SCREW WAS TIGHTENED CORRECTLY. THIS REPORT IS #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 TORQUE LIMITER, PLATE