BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE FOR FRACTURE SCREWS 2.0 / 2.3 / 2.7MM UNIVERSAL FRACTURE MODUL

    MDR report key: 3773510 · Received April 25, 2014

    Report

    Report Number
    0008010177-2014-00113
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE. DEVICE DISCARDED.

    Additional Manufacturer Narrative · 1

    A CONFIRMATION OF THE REPORTED EVENT WAS NOT APPLICABLE BECAUSE THE INVOLVED PRODUCTS WILL NOT BE AVAILABLE FOR CONCURRENT INVESTIGATION. RELATED TO THE SCREWDRIVER BLADE WITH CATALOG # 62-20130 AND RELATED TO THE UNIVERSAL CHEEK RETRACTOR WITH CATALOG # 62-00414 (AS REPORTED) TWO SYSTEMS - THE MANDIBLE FRACTURE SYSTEM AND THE ORTHOGNATHIC SYSTEM ¿ CAN BE ASSIGNED. CONCERNING TO BOTH SYSTEMS AND RELATED TO SCREWDRIVER BLADE WITH CATALOG # 62-20130 AND UNIVERSAL CHEEK RETRACTOR WITH CATALOG # 62-00414 THE FOLLOWING COMPONENTS ARE SUITABLE FOR ASSEMBLING: MANDIBLE FRACTURE SYSTEM - CATALOG # 62-20130 - SCREWDRIVER BLADE FOR FRACTURE SCREWS 2.0 / 2.3 / 2.7MM; CATALOG # 62-00414 - UNIVERSAL CHEEK RETRACTOR, WITH LIGHT SOURCE; CATALOG # 62-00400 - UNIVERSAL TROCAR HANDLE, NO CANNULA; CATALOG # 62-00416 - UNIVERSAL MANDIBLE CANNULA FOR 62-00400, TRAUMA TIP. ORTHOGNATHIC SYSTEM - CATALOG # 62-20130 - SCREWDRIVER BLADE FOR FRACTURE SCREWS 2.0 / 2.3 / 2.7MM; CATALOG # 62-00414 - UNIVERSAL CHEEK RETRACTOR, WITH LIGHT SOURCE; CATALOG # 62-00400 - UNIVERSAL TROCAR HANDLE, NO CANNULA; CATALOG # 62-00409 - CANNULA FOR 62-00400, SERRATED TIP; CATALOG # 62-00415 - CANNULA FOR 62-00400, POINTED TIP. REGARDING THE DEVELOPMENT OF THE DESIGN AND COMPATIBILITY OF ALL COMPONENTS IN THE NEWEST UNIVERSAL TROCAR SYSTEM A THOROUGHLY INTERFACE ANALYSIS CONCERNING THE GEOMETRY AND FUNCTION, IMPACT ANALYSIS AND HANDLING TESTS WERE PERFORMED BEFORE MARKET LAUNCH. FURTHERMORE THE RELATED COMPONENTS OF THE NEWEST UNIVERSAL TROCAR SYSTEM ARE COLOR-CODED AND THEREFORE IDENTIFIABLE. SINCE MARKET LAUNCH THE CURRENT COMPLAINT IS THE FIRST ONE RECORDED REPORTING A PROBLEM WITH THE COMPONENTS COMPATIBILITY. BASED ON THE INVESTIGATION THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES COULD HAVE BEEN: WRONG COMPONENTS WERE USED FOR THE NEWEST UNIVERSAL TROCAR SYSTEM ¿ MIXED UP COMPONENTS. WRONG OR NOT CORRECTLY ASSEMBLING OF THE RELATED COMPONENTS. DEVICE WAS NOT ABLE TO BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING SURGERY, THE SCREWDRIVER BLADE WAS NOT LONG ENOUGH TO TIGHTEN THE SCREWS FULLY. THE SURGEON STRUGGLED AND EVENTUALLY THE SCREWDRIVER HANDLE DISENGAGED WHEN IT CAME UP AGAINST THE PATIENT'S CHEEK. SURGEON MANAGED TO TIGHTEN SCREWS.

    Description of Event or Problem · 1

    DURING SURGERY, THE SCREWDRIVER BLADE WAS NOT LONG ENOUGH TO TIGHTEN THE SCREWS FULLY. THE SURGEON STRUGGLED AND EVENTUALLY THE SCREWDRIVER HANDLE DISENGAGED WHEN IT CAME UP AGAINST THE PATIENT'S CHEEK. SURGEON MANAGED TO TIGHTEN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251547 SCREWDRIVER BLADE FOR FRACTURE SCREWS 2.0 / 2.3 / 2.7MM UNIVERSAL FRACTURE MODUL INSTRUMENT LXH STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1