BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 3910366 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02492
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 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 & 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 HAS BEEN NO OTHER EVENT FOR THE MANUFACTURING LOT. CONCLUSIONS: THE ROOT CAUSE WAS DETERMINED TO BE APPLICATION OF EXCESSIVE FORCE BY THE USER. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTIVE ACTION: A CAPA PERFORMED AN INVESTIGATION INTO REPORTS OF FRACTURED TRIDENT DRIVER TIPS. THE INVESTIGATION FOUND THAT THE FAILURE MODE IS OBSERVED WHEN THE DRIVER IS OVER TORQUED, THE DRIVER TIP WEARS EXCESSIVELY DUE TO REPEATED USE OF THE DRIVER, OR WHEN THE DRIVER TIP IS ANGULATED EXTREMELY WITHIN THE SCREW HEAD DURING USE. AN ECN WAS IMPLEMENTED ON MAY, 2005 TO IMPROVE THE FIT OF THE DRIVER TIP AND SCREW HEAD AND REDUCE THE LIKELIHOOD OF DRIVER TIP DEFORMATION. ALTHOUGH THE DESIGN WAS IMPROVED, THE RESULTS OF THE DESIGN VALIDATION TESTING INDICATED THAT THE TIP REMAINED SUSCEPTIBLE TO DEFORMATION AT EXTREME ANGULATIONS OF THE DRIVER TIP WITHIN THE SCREW HEAD. THE DESIGN INTENT OF THE DRIVER TIP IS TO DEFORM RATHER THAN TO DEFORM AND/OR BREAK THE SCREW (IMPLANT).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, 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. THE DR WANT TO KNOW THE METHOD OF THE SCREW REMOVAL WHEN THE REVISION OPERATION WILL BE DONE AT THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, 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. THE DR WANT TO KNOW THE METHOD OF THE SCREW REMOVAL WHEN THE REVISION OPERATION WILL BE DONE AT THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387767 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH F6V13600

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other