BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH STOP ADAPTER

    MDR report key: 1659131 · Received April 13, 2010

    Report

    Report Number
    3005677147-2010-00003
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 10, 2010
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K003776
    Removal / Correction Number
    3005677147-4/09/10-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE PRODUCT WAS PERFORMED BY DISTRIBUTOR REPRESENTATIVE AT THE SURGERY. THIS EVALUATION FOUND THAT THE SCREW USED TO FIXATE THE LEAD WITHIN THE DBS DEPTH STOP ADAPTER HAD BENT THE LEAD WITHIN THE STYLET. A SPECIFIC WARNING IN THE DFU EXISTS FOR THIS DEVICE STATING THAT OVERTIGHTENING OF THE SCREW MAY DAMAGE THE LEAD. THE SCREW FIXATING THE LEAD HAD RECENTLY BEEN CHANGED FROM A FLAT-TIPPED SCREW TO ONE WITH A ROUND TIP. HOWEVER, THE VERIFICATION AND VALIDATION FAILED TO SHOW THE POSSIBILITY OF THE NEW SCREW DAMAGING THE LEAD IF IT WAS OVERTIGHTENED. SUBSEQUENT FIELD ACTION IS UNDERWAY FOR THIS PRODUCT.

    Description of Event or Problem · 1

    DISTRIBUTOR SALES REPRESENTATIVE CONTACTED FHC SALES PERSON TO REPORT A BENT STYLET WITHIN A DBS LEAD. THIS OCCURRED WHEN SETTING THE DBS DEPTH STOP ADAPTER ON THE SECOND LEAD IN A BILATERAL PLATFORM SURGERY. THE STYLET OF THE LEAD BECAME BENT WHEN THE DEPTH STOP SCREW WAS TIGHTENED. THE SURGERY CONTINUED WITH A DIFFERENT STYLET WITHIN THE LEAD AND WITH A DIFFERENT SCREW WITHIN THE DEPTH STOP ADAPTER. THERE WERE NO FURTHER SURGERY DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPTH STOP ADAPTER HAW FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROTARGETING DRIVE SYSTEM| WAYPOINT STEREOTACTIC SYSTEM PLATFORM