BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 3844873 · Received June 3, 2014

    Report

    Report Number
    0002249697-2014-02036
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED HEXALOBULAR SCREWDRIVER TIP FROM A TRIDENT DRIVER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RETURNED IN USED CONDITION. THE TIP OF THE HEXALOBULAR FEATURE IS FRACTURED; DEFORMATION TO THE REMAINING PORTION INDICATES THE FRACTURE OCCURRED WHILE TIGHTENING A SCREW, CONSISTENT WITH THE EVENT DESCRIPTION. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF MEDICAL RECORDS WAS NOT PERFORMED AS NONE WERE PROVIDED. NO FURTHER INFORMATION WAS REQUESTED AS THERE IS NO INDICATION THE FAILURE WAS RELATED TO PATIENT FACTORS. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND THERE HAVE BEEN OTHER EVENTS FOR THE MANUFACTURING LOT. PREVIOUS INVESTIGATIONS HAVE FOUND THE ROOT CAUSE TO BE RELATED TO EXCESSIVE TORQUE APPLIED TO THE DEVICE BY THE USER. CONCLUSIONS: THE ROOT CAUSE WAS DETERMINED TO BE APPLICATION OF EXCESSIVE FORCE BY THE USER.

    Description of Event or Problem · 1

    DURING A THA, WHEN A SURGEON SCREWING A SCREW, THE TIP OF DRIVER BROKE. HE ATTEMPTED TO REMOVE THE FRAGMENT FROM THE SCREW HEAD BUT HE COULD NOT REMOVE IT. BECAUSE, IT GOT STUCK INTO THE HEAD. THEREFORE, HE IMPLANTED INSERT AS IS.

    Description of Event or Problem · 1

    DURING A THA, WHEN A SURGEON SCREWING A SCREW, THE TIP OF DRIVER BROKE. HE ATTEMPTED TO REMOVE THE FRAGMENT FROM THE SCREW HEAD BUT HE COULD NOT REMOVE IT. BECAUSE, IT GOT STUCK INTO THE HEAD. THEREFORE, HE IMPLANTED INSERT AS IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325204 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH F5A9383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other