BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN ROTATING HINGE KNEE SCREW DRIVER

    MDR report key: 1860176 · Received September 21, 2010

    Report

    Report Number
    1822565-2010-00783
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IN GENERAL, A POTENTIAL CAUSE FOR THE HINGE POST EXTENSION REQUIRING EXCESSIVE TORQUE TO REMOVE IS APPLYING TOO MUCH TORQUE AT THE TIME THE DEVICE WAS ORIGINALLY IMPLANTED. IN THIS CASE, IT IS UNK IF THE APPROPRIATE TORQUE WAS APPLIED WHEN INITIALLY IMPLANTED OR IF ANY ALTERNATIVE SURGICAL TECHNIQUE WAS ATTEMPTED; THEREFORE, WITH THE AVAILABLE INFO AN EXACT ROOT CAUSE CANNOT BE DETERMINED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE DISTRIBUTION HISTORY SHOWS THAT THE INSTRUMENT HAS BEEN IN THE FIELD FOR APPROXIMATELY 1 YEAR AND 7 MONTHS; HOWEVER, THE ACTUAL USAGE OF THE DEVICE IS UNK. SEM ANALYSIS OF THE FRACTURED TIP SHOWS ELONGATED DIMPLES INDICATING THAT THE FRACTURE OCCURRED BY OVERLOAD IN TORSION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP OF THE HEX SCREWDRIVER FRACTURED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ROTATING HINGE KNEE SCREW DRIVER KNEE INSTRUMENT HXX ZIMMER INC. 61199152

    Patients

    Seq Age Sex Outcome Treatment
    1