BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5X90MM CANN CANC SCR 22

    MDR report key: 2133409 · Received June 13, 2011

    Report

    Report Number
    1818910-2011-10281
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 14, 2011
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HWC
    PMA / PMN Number
    K872859
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED SCREW BY A DEPUY (B)(4) MATERIAL RESEARCH SCIENTIST CONFIRMED THE COMPLAINT. THE PRESENCE OF DUCTILE DIMPLES INDICATES THE CRACKS IN THE SCREW TIP WERE DUE TO AN OVERLOAD FAILURE. THE FORCE APPLIED EXCEEDED THE ULTIMATE STRENGTH OF THE MATERIAL AND THE MATERIAL CRACKED AS A RESULT OF DUCTILE OVERLOAD FAILURE. THESE CRACKS ARE LIKELY DUE TO INCREASED STRESSES AT THE SCREW TIP, WHICH COULD BE DUE TO HARD OR SCLEROTIC BONE OR AN UNDERSIZED DRILLED HOLE DURING INSERTION OF THE SCREW. NO MATERIAL DEFECTS WERE OBSERVED IN THE BONE SCREW THAT COULD HAVE CONTRIBUTED TO CRACK INITIATION AND/OR PROPAGATION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION AND FOUND NO OTHER REPORTS FOR THIS PRODUCT CODE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    WHILE INSERTING A 6.5 CANNULATED SCREW INTO THE PT'S FEMORAL HEAD, THE TIP OF THE SCREW APPARENTLY FLARED OUTWARD AFTER GOING THROUGH HARD BONE IN THE FEMORAL NECK. THE ISSUE CAUSED A 45 MINUTES DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5X90MM CANN CANC SCR 22 87 HWC HWC DEPUY ACE S.A. 'R.L. NA DLKBZF

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR