BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGENCY BONE SCREWS, CROSS-FIT, SELF-TAPPING, DI

    MDR report key: 1679224 · Received April 30, 2010

    Report

    Report Number
    8010177-2010-00198
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 9, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FRIEBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE COULD NOT BE DETERMINED. THE EMERGENCY SCREW 52-19205 HAS AS DIAMETER OF 1.9MM AND IS PART OF THE MINI WURZBURG SYSTEM. IN THIS SYSTEM ARE DRILLS AVAILABLE WITH 1.3MM DIAMETERS. THE EMERGENCY SCREW 52-23706 AND ALL OTHER EMERGENCY SCREWS HAVE A DIAMETER OF 2.3MM AND ARE PARTS OF THE STEINHOUSER IMPLANTS SYSTEM. IN THIS SYSTEM ARE DRILL AVAILABLE WITH 1.5MM DIAMETERS. EVEN IF THE SURGEON MIXED UP THE DRILLS OF BOTH SYSTEMS, IT WOULD HAVE BEEN POSSIBLE TO INSERT THE EMERGENCY SCREWS WITHOUT IDLING (1.9MM SCREW IN A 1.5MM DRILL HOLE). SO IT IS MOST LIKELY THAT THE PATIENT HAD A BAD BONE QUALITY OR THE SURGEON USED A DRILL FROM ANOTHER SYSTEM WITH A BIGGER DIAMETER, WHAT CAUSED THE IDLING EMERGENCY SCREWS.

    Description of Event or Problem · 1

    DURING OSTEOTOMY SURGERY, THE SURGEON USED THE SCREW OF 1.7MM FOR MAXILLA BONE OF PATIENT, AND THE SCREW OF 2.0MM FOR MANDIBLE BONE OF PATIENT. AT THAT TIME, THE SURGEON USED THE EMERGENCY SCREW BECAUSE THE SCREW HAD RUN IDLE. TWO EMERGENCY SCREWS RAN IDLE THOUGH EMERGENCY SCREW WAS USED. THE SURGEON WAS COMPLETED BY USING ANOTHER EMERGENCY SCREW. BECAUSE IT WAS A PATIENT OF THE INFECTIOUS DISEASE, THE SCREW WAS DISCARDED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERGENCY BONE SCREWS, CROSS-FIT, SELF-TAPPING, DI IMPLANT JEY STRYKER OSTEOSYNTHESIS FRIEBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK