BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 3022846 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01077
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED SCREWDRIVER TIP FROM A TRIDENT DRIVER WAS REPORTED. THE EVENT WAS CONFIRMED. 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. DAMAGE TO THE ASSOCIATED SCREW SUGGESTS IT WAS NOT PROPERLY ALIGNED IN THE ACETABULAR SHELL WHICH LIKELY INCREASED THE AMOUNT OF TORQUE NECESSARY TO DRIVE THE SCREW AND CONTRIBUTED TO THE FRACTURE. ADDITIONALLY, THE FRACTURE SURFACE IS ANGLED WHICH SUGGESTS THE DRIVER WAS NOT FULLY ENGAGED WITH THE SCREW DURING TIGHTENING. IT IS NOT BELIEVED 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. THE ROOT CAUSE WAS DETERMINED TO BE APPLICATION OF EXCESSIVE FORCE BY THE USER. AN IMPROPERLY ALIGNED SCREW LIKELY NECESSITATED THE EXCESSIVE TORQUE. NO MATERIAL OR MANUFACTURING DEFECTS WERE NOTED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE THA, WHEN THE SURGEON WAS SCREWING A SCREW WITH A UNIVERSAL DRIVER, THE TIP OF THE DRIVER BROKE IN THE SCREW HEAD. HE REMOVED THE FRAGMENT AND THE SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE THA, WHEN THE SURGEON WAS SCREWING A SCREW WITH A UNIVERSAL DRIVER, THE TIP OF THE DRIVER BROKE IN THE SCREW HEAD. HE REMOVED THE FRAGMENT AND THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126262 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH F1V3379

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other