BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE REVISION SCREWOUT

    MDR report key: 1001862 · Received February 25, 2008

    Report

    Report Number
    1221934-2008-00096
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE COMPLAINT DEVICE. WHEN THE DEVICE IS RECEIVED, IT WILL BE SUBJECTED TO A ROOT CAUSE FAILURE ANALYSIS. THE RESULTS OF THAT EVALUATION WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING A KNEE REPAIR, IN THE PROCESS OF DRIVING A FIXATION SCREW INTO THE BONE TUNNEL, A PORTION OF THE DISTAL TIP OF THE DRIVER BROKE OFF INTO THE SCREW. ALL OF THE DEBRIS, INCLUDING THE DAMAGED FIXATION DEVICE WAS REMOVED FROM THE BODY. THE SURGEON COMPLETED THE REPAIR SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE REVISION SCREWOUT ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 219381 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK