BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 2944378 · Received February 5, 2013

    Report

    Report Number
    0002249697-2013-00572
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. 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. THE EVENT DESCRIPTION NOTED THE SCREW WAS FULLY SEATED AT THE TIME OF THE EVENT; IT IS LIKELY THAT FURTHER TORQUE APPLIED TO THE SEATED SCREW CAUSED THE DRIVER TO FRACTURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE TIP OF SCREWDRIVER CATALOG # 2107-1015, WITH LOT CODE F7N16747 BROKE OFF WHILE INSERTING A 6.5 MM SCREW (B)(4) INTO AN ACETABULAR SHELL. SCREW WAS ALREADY FULLY INSERTED, SO THE ACETABULAR INSERT WAS IMPACTED AND THE PROCEDURE CONTINUED WITHOUT A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE TIP OF SCREWDRIVER CATALOG # 2107-1015, WITH LOT CODE F7N16747 BROKE OFF WHILE INSERTING A 6.5 MM SCREW 2030-6525-1 INTO AN ACETABULAR SHELL. SCREW WAS ALREADY FULLY INSERTED, SO THE ACETABULAR INSERT WAS IMPACTED AND THE PROCEDURE CONTINUED WITHOUT A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48927 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH F7N16747

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other