BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE, CANNULATED

    MDR report key: 3007630 · Received March 15, 2013

    Report

    Report Number
    0008010177-2013-00043
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INVESTIGATION REVEALED THAT THE FRONT PART OF THE TIP (HEXAGON) WAS BROKEN AND THE FRACTURED SURFACE SHOWED APPEARANCE OF A FORCED RUPTURE RESULTING FROM TORSIONAL AND BENDING OVERLOAD. THE PLASTIC DEFORMATION OF THE HEXAGON EDGE AT THE REMAINING FLANK POINTED TO THE FACT THAT TOO HIGH TORSIONAL FORCES WERE APPLIED IN TURN DIRECTION DURING APPLICATION. THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED ISSUE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    CURRENTLY THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE. (B)(4): DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT BREAKAGES OCCURRED IN SCAPHOID NON-UNION FIXATIONS WHERE THE BONE IS SCLEROTIC. WHILE THE SCREW PROGRESSED NORMALLY TILL THE LEADING EDGE WAS INSIDE THE BONE AND WHEN THE ¿BLUE¿ END CONTACTED THE BONE AND RESISTANCE INCREASED, THE END OF SCREW DRIVER BROKE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT BREAKAGES OCCURRED IN SCAPHOID NON-UNION FIXATIONS WHERE THE BONE IS SCLEROTIC. WHILE THE SCREW PROGRESSED NORMALLY TILL THE LEADING EDGE WAS INSIDE THE BONE AND WHEN THE "BLUE" END CONTACTED THE BONE AND RESISTANCE INCREASED, THE END OF SCREW DRIVER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109418 SCREWDRIVER BLADE, CANNULATED INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG TBC

    Patients

    Seq Age Sex Outcome Treatment
    1