BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE, T7, AO

    MDR report key: 3033816 · Received April 3, 2013

    Report

    Report Number
    0008010177-2013-00055
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE SCREWDRIVER BLADE WAS BROKEN COULD BE CONFIRMED. THE VISUAL EXAMINATION SHOWED THAT ALL FLANKS OF THE TIP/TORX OF THE RETURNED SCREWDRIVER BLADE WERE HEAVILY, PLASTICALLY DEFORMED IN TURN DIRECTION. THE DIRECTION OF THE PLASTIC DEFORMATIONS OF THE FLANKS POINTS TO THE INFLUENCE OF TOO HIGH TORSIONAL FORCES DURING APPLICATION. FURTHERMORE, A METAL FRAGMENT OF ONE FLANK IS BROKEN OFF. THE FRACTURE SURFACE AT THE FLANK SHOWS APPEARANCE OF A FORCED RUPTURE. MOREOVER, PRESSURE MARKS AT THE SLOT AREA OF THE BLADE ARE VISIBLE INDICATING HIGH BENDING FORCES. BASED ON THE PERFORMED INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED ISSUE OF HIGH TORSIONAL AND BENDING OVERLOAD ON THE BLADE. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT FOUND IN THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRIVER BLADE WAS BROKEN.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRIVER BLADE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136187 SCREWDRIVER BLADE, T7, AO INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG AC10

    Patients

    Seq Age Sex Outcome Treatment
    1