BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2802457 · Received October 18, 2012

    Report

    Report Number
    1226188-2012-00061
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 18, 2012
    Manufacturer
    OMNLIFE SCIENCE
    Product Code
    JWH
    PMA / PMN Number
    K101994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RETURNED INSTRUMENT INDICATES THAT BURRS ARE PRESENT IN ALL OF THE HOLES ON THE DRILL/SIZING GUIDE. THE DRILL IS WORN OUT OVER TIME FROM REPEATED USE. IF THE DRILL IS NOT INSERTED AXIAL TO THE HOLE IN THE DRILL GUIDE, THEN BURRS ON THE INSIDES OF THE HOLES IN THE DRILL GUIDE CAN BE CREATED. AS THE BURRS BUILD UP OVER TIME, THE HOLE DIAMETER WILL DECREASE, EVENTUALLY PREVENTING THE DRILL FROM FITTING INTO THE HOLES.

    Description of Event or Problem · 1

    THE PATELLA DRILL BIT WAS STICKING IN THE SIZE 32 PATELLA SIZER. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX KNEE SYSTEM PATELLA POST DRILL JWH OMNLIFE SCIENCE G1010

    Patients

    Seq Age Sex Outcome Treatment
    1