BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE, CANNULATED

    MDR report key: 3183007 · Received June 21, 2013

    Report

    Report Number
    0008010177-2013-00124
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INVESTIGATION OF THE INNER BLADE REVEALED THAT A PART OF THE HEXAGON WAS BROKEN AT THE TIP AREA BUT NOT RETURNED. THE FRACTURED SURFACE HAD THE APPEARANCE OF A FORCED RUPTURE. FURTHERMORE, IT WAS DETERMINED THAT THE HEXAGON EDGE OF THE REMAINING FLANK SHOWED NO PLASTIC DEFORMATIONS IN TURN IN AND TURN OUT DIRECTION WHICH COULD POINT TO TORSIONAL OVERLOAD DURING APPLICATION. MOREOVER, SECONDARY CRACKS AT THE REMAINING HEXAGON PART WERE VISIBLE RESULTING FROM BENDING OVERLOAD. IT WAS ALSO DETECTED THAT THE BENDING ZONE AT THE REMAINING HEXAGON PART INDICATED A STRONG WOBBLING ACTION SINCE TOO HIGH BENDING FORCES WERE APPLIED DURING APPLICATION LEADING TO SECONDARY CRACKS AND FINALLY TO THE BREAKAGE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED HANDLING ISSUE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN DURING INSERTION OF THE SCREW. THE SCREW COULDN`T BE MOVED ANYMORE. THERE WAS A DELAY OF 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282649 SCREWDRIVER BLADE, CANNULATED INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1