BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX 2.7MM BTB BR CROSS PIN KIT

    MDR report key: 2062277 · Received March 18, 2011

    Report

    Report Number
    1221934-2011-00123
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HTY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC ACL PROCEDURE, A PORTION OF THE DISTAL END OF A RIGIDFIX GUIDE SLEEVE BROKE OFF INTO THE PT'S CONDYLE. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT FROM THE BONE, AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE SURGEON DID NOT USE THE PROPER TOOL OR TECHNIQUE IN HIS ATTEMPT TO REMOVE THE GUIDE SLEEVE. INSTEAD OF USING THE RECOMMENDED SLEEVE REMOVAL TOOL AND PULLING IN A STRAIGHT LINE DIRECTION, THE SURGEON ATTEMPTED THE SLEEVE EXTRACTION BY USING HIS HANDS AS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX 2.7MM BTB BR CROSS PIN KIT SOFT TISSUE FIXATION DEVICE HTY DEPUY MITEK 210815 3434791

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK