BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREPHINE 11MM ID X 5.5 IN

    MDR report key: 1017726 · Received March 14, 2008

    Report

    Report Number
    1818910-2008-00712
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE INSTRUMENTS WOULD NOT CUT PROPERLY CAUSING A 45 - 60 MINUTE EXTENTION OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREPHINE 11MM ID X 5.5 IN 87LXH HWK DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR