BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 2962907 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-00154
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD BE RELEVANT TO THIS COMPLAINT. THE HEX TIP IS MOSTLY BROKEN OFF ON THE RETURNED DEVICE. THE RETURNED DEVICE WAS MANUFACTURED IN DECEMBER 1999 AND IS OVER 13 YEARS OLD. THE SHAFT COMPONENT PART 314.05.01, LOT 4029608 WAS MANUFACTURED IN DECEMBER 1999 FROM 440A SS MATERIAL. THIS ISSUE WAS ADDRESSED ON SEVERAL PRIOR COMPLAINTS AND CORRECTIVE ACTION 1180 WAS INITIATED TO ADDRESS IT. AS PART OF THE CORRECTIVE ACTION, THE MATERIAL WAS CHANGED FROM 440A STAINLESS STEEL TO 465PH STAINLESS STEEL, DCO 0702039. THE DEVICE IN THIS COMPLAINT WAS PRODUCED IN DECEMBER 1999 PRIOR TO IMPLEMENTATION OF THE CORRECTIVE ACTION. THE DESIGN RISK ANALYSIS IS ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    DURING A LIMITED ANKLE FUSION PROCEDURE, THE SURGEON WAS INSERTING FOUR 7.3MM CANNULATED SCREWS AND ON INSERTING THE FOURTH SCREW, THE TIP OF THE SCREWDRIVER BROKE OFF. THE TIP OF THE SCREWDRIVER WAS RETRIEVED AND DISCARDED, NO FRAGMENTS WERE LEFT BEHIND. THE SURGEON USED ANOTHER SCREWDRIVER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68491 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE 4049147

    Patients

    Seq Age Sex Outcome Treatment
    1