BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 3201799 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04211
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGERY ON (B)(6)2013, THE POWER SCREWDRIVER TIP BROKE OFF IN THE HEAD OF A 3.5 MM CORTEX SCREW. THE BROKEN PORTION OF THE SCREWDRIVER TIP REMAINS IMPLANTED. IT WAS REPORTED THAT THE SCREW WAS TIGHTENED FLUSH JUST PRIOR TO THE BREAKAGE THEREFORE, THE SURGEON COMPLETED THE PROCEDURE. SURGERY WAS DELAYED APPROXIMATELY 10 MINUTES WHILE THE SURGEON ATTEMPTED TO RECOVER THE BROKEN PORTION FROM THE SCREW HEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301018 SMALL HEXAGONAL SCREWDRIVER SHAFT HXX SYNTHES GMBH 3383545

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR