BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY MITEK ACL INSTRUMENTS

    MDR report key: 1051660 · Received May 19, 2008

    Report

    Report Number
    1221934-2008-00280
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 19, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE COMPLAINT HAS NOT BEEN RECEIVED. DEPUY MITEK IS IN THE PROCESS OF TRYING TO OBTAIN MORE INFORMATION ABOUT THE EVENT, AND RETRIEVING THE DEVICE FOR ROOT CAUSE ANALYSIS. WHEN MORE INFORMATION AND THE DEVICE IS RECEIVED THE RESULTS WILL BE REFLECTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS DRILLING, THE DRILL GUIDES BENT CAUSING METAL SHAVINGS THAT FELL INTO THE PATIENT. SUCTION WAS USED TO GET THE SHAVINGS OUT. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY MITEK ACL INSTRUMENTS RIGIDFIX ST GUIDE FRAME HTY DEPUY MITEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK