BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR DRIVER - 23MM

    MDR report key: 2081074 · Received April 14, 2011

    Report

    Report Number
    1221934-2011-00166
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED OFF THE SALES REP'S DESCRIPTION OF THE EVENT AND HISTORICALLY FROM PRIOR SIMILAR COMPLAINTS FOR THIS DEVICE, WE BELIEVE THE ROOT CAUSE FOR THE REPORTED FAILURE MODE OF THE COMPLAINT DEVICE WAS LIKELY DUE TO EXCESSIVE MECHANICAL FORCE BEING APPLIED BY THE USER RESULTING IN THE TWISTING AND BREAKAGE OF THE TIP. WHILE THERE IS NO CERTAINTY, CONTRIBUTING FACTORS COULD HAVE BEEN IMPROPER TUNNEL SIZING OF THE BONE HOLE OR OFF ANGLE INSERTION OF THE SCREW INTO THE PATIENT'S BONE. THE COMPLAINT DEVICE IS BEING RETURNED FOR EVALUATION. SHOULD THE EVALUATION OF THE COMPLAINT DEVICE RESULT IN A DIFFERENT HYPOTHESIS THAN DESCRIBED ABOVE, A FOLLOW-UP REPORT WILL BE FILED TO REPORT THE FINDINGS. AT THIS TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    OUR SALES REP REPORTED TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, THE DISTAL TIP OF A 23 MM MODULAR DRIVER BROKE AS THE SURGEON WAS DRIVING THE FIXATION SCREW INTO THE BONE TUNNEL. THE FRAGMENT WAS EASILY REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE SALES REP STATED THAT THE MILAGRO INTERFERENCE SCREW BEING INSERTED BY THE COMPLAINT DEVICE, WAS FULLY SEATED IN ITS PROPER POSITION WHEN THE TIP OF THE DRIVER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR DRIVER - 23MM ARTHROSCOPIC INSTRUMENT HXX DEPUY MITEK 219957 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK