BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER HEX CANNULATED SCREWDRIVER

    MDR report key: 4180513 · Received October 15, 2014

    Report

    Report Number
    1822565-2014-01391
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HXX
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE HEX DRIVER COULD HAVE FRACTURED DUE TO OFF-AXIS ECCENTRIC LOADING OR IF THE DRIVER WAS USED UNDER POWER DURING FINAL TIGHTENING OF SCREWS. THE SURGICAL TECHNIQUE INFORMS THE USER TO COMPLETE FINAL TIGHTENING BY HAND TO PREVENT POTENTIAL SCREW CROSS-THREADING OR DAMAGE TO THE SCREW OR DRIVER. IF EXCESSIVE TIGHTENING LOAD IS REQUIRED TO SEAT SCREWS, SURGEONS ARE ADVISED TO USE A SOLID 2.5 MM HEX DRIVER. THE INSTRUMENT HAD A POTENTIAL FIELD AGE OF APPROXIMATELY 1 YEAR AT THE TIME OF INCIDENT WITH AN UNKNOWN USAGE HISTORY. BASED ON INFORMATION PROVIDED, THE DEFINITIVE ROOT CAUSE OF THIS ISSUE CANNOT BE ESTABLISHED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. AS RETURNED, THE TIP WAS COMPLETELY BROKEN OFF WHILE THERE APPEARED TO BE NO FURTHER PHYSICAL DAMAGE OR SCRATCHES. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED DOES NOT CHANGE PREVIOUS INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE KIT INSPECTION IT WAS FOUND THAT THE TIP OF THE DRIVER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655702 ZIMMER HEX CANNULATED SCREWDRIVER HXX ZIMMER, INC. 62423473

    Patients

    Seq Age Sex Outcome Treatment
    1