BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER, SELF-HOLDING, EXTRA SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM

    MDR report key: 4220588 · Received November 3, 2014

    Report

    Report Number
    0009610622-2014-00615
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. EVALUATION REVEALED THE SCREWDRIVER TO BE THE PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR AT LEAST 2 AND A HALF YEARS WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. THE BREAKAGE SURFACE SHOWS THE TYPICAL STRUCTURE OF A BRITTLE FRACTURE, DUE TO A BENDING OVERLOAD. TO PREVENT BENDING THE SCREWDRIVER IS LASER-MARKED WITH THE PRINTING ¿DO NOT LEVER¿. FURTHERMORE IT IS RECOMMENDED THAT THE SCREWDRIVER SHALL BE TREATED WITH AN APPROPRIATE INSTRUMENT SPRAY AFTER EVERY USAGE. A PROCESS CHANGE WAS PERFORMED; THE WCH COATING WAS REMOVED TO PREVENT BREAKAGES OF THE MOVEABLE BLADE. THE RETURNED SCREWDRIVER MANUFACTURING DATE POST-DATES THE PROCESS CHANGE. HOWEVER, NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND; THE BREAKAGE WAS CAUSED BY AN IMPROPER HANDLING. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    THE TIP OF THIS SCREWDRIVER HAS A SPLIT IN IT, WHICH SPLAYS TO LOCK INTO THE SCREW HEAD. THE SMALL TIP HAS BROKEN OFF. THE LAST PATIENT'S SURGERY THAT THIS SCREWDRIVER WAS USED IN THE X-RAYS HAVE BEEN REVIEWED AND THERE IS NO EVIDENCE THAT THE TIP OF THE SCREWDRIVER WAS LEFT BEHIND. THE SCRUB SCOUT STAFF NOTED THAT THE INSTRUMENT WAS ALREADY ASSEMBLED WHEN IT CAME DOWN FROM CSSD AND THAT IS UNKNOWN HOW LONG THE FRAGMENT HAS BEEN MISSING.

    Description of Event or Problem · 1

    THE TIP OF THIS SCREWDRIVER HAS A SPLIT IN IT, WHICH SPLAYS TO LOCK INTO THE SCREW HEAD. THE SMALL TIP HAS BROKEN OFF. THE LAST PATIENTS SURGERY THAT THIS SCREWDRIVER WAS USED IN THE X-RAYS HAVE BEEN REVIEWED AND THERE IS NO EVIDENCE THAT THE TIP OF THE SCREWDRIVER WAS LEFT BEHIND. THE SCRUB SCOUT STAFF NOTED THAT THE INSTRUMENT WAS ALREADY ASSEMBLED WHEN IT CAME DOWN FROM CSSD AND THAT IS UNKNOWN HOW LONG THE FRAGMENT HAS BEEN MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703335 SCREWDRIVER, SELF-HOLDING, EXTRA SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KP341880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other