BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEAK FX KEY SCR COUPLING ROD

    MDR report key: 1071251 · Received July 7, 2008

    Report

    Report Number
    1818910-2008-02584
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE TIP BROKE OFF. A DEPUY WARSAW MATERIAL RESEARCH MANAGER EXAMINED THE FRACTURED SURFACE. THE FRACTURED SURFACE SHOWS A SLIGHT TORSIONAL FRACTURE, HOWEVER, THE PREVAILING FRACTURE MODE IS CANTILEVER. A SECONDARY CRACK IS SHOWN AT THE ROOT OF THE THREAD INDICATING A BENDING ACTION IN CANTILEVER. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PRODUCT NUMBER. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THREADED INSERTER INSTRUMENT BROKE OFF INSIDE THE KEYED LOCKING DEVICE EXTENDING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK FX KEY SCR COUPLING ROD 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA AG0407

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR