BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN FEMORAL AUGMENT SCREWDRIVER

    MDR report key: 2062898 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00661
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    December 29, 2009
    Report Date
    January 6, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ALL MEASURED DIMENSIONS (INCLUDING HARDNESS) WERE FOUND TO BE CONFORMING. IT APPEARS THAT THE CAUSE FOR THIS INCIDENT IS THE EXCESSIVE FORCE THAT WAS APPLIED TO THE INSTRUMENT. THE RETURNED DEVICE WAS FOUND TO BE DIMENSIONALLY CONFORMING TO PRINT SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE SCREW BECAME CROSS THREADED, THE SURGEON TURNED THE SCREWDRIVER WITH MORE FORCE TO TRY TO REMOVE THE SCREW AND THE HEX HEAD SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FEMORAL AUGMENT SCREWDRIVER KNEE INSTRUMENT HXX ZIMMER, INC. 60918715

    Patients

    Seq Age Sex Outcome Treatment
    1