BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK RIGIDFIX 3.3 ST CROSS PIN KIT

    MDR report key: 1182711 · Received September 25, 2008

    Report

    Report Number
    1221934-2008-00462
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 3, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A FAILURE ANALYSIS. THE EVALUATION'S CONCLUSIONS WILL BE THE SUBJECT OF THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT A PT HAD A KNEE PROCEDURE WITH THE USE OF RIGIDFIX CROSS PINS FOR FIXATION ON AN UNDETERMINED DATE. AT SOME TIME SUBSEQUENT TO THIS SURGERY THE PT RE-INJURED THE SAME KNEE, THIS RE-INJURY OF THE ACL WAS INFLICTED BY OUTSIDE ACTIVITIES TOTALLY UNRELATED TO THE ORIGINAL SURGERY AND THE FIXATION DEVICE. HOWEVER, AT THE 2ND SURGERY, (B)(6) 2008, IT WAS NOTED THAT A PORTION OF ONE OF THE RIGIDFIX CROSS PINS HAD BROKEN AWAY AND MIGRATED INTO THE PT'S JOINT SPACE. THE PT WAS NOT AFFECTED BY THIS LOOSE FRAGMENT. THE NEWLY DAMAGED ACL WAS YET AGAIN REPAIRED, THE PIN FRAGMENT WAS REMOVED FROM THE BODY, AND THIS PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. ALTHOUGH IT IS REPORTED THAT THERE IS NO PT CONSEQUENCE, IF THIS WAS TO RECUR, IT IS POSSIBLE THAT PT INJURY COULD POTENTIALLY...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK RIGIDFIX 3.3 ST CROSS PIN KIT SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK 210133 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK