BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMER PAD SMALL

    MDR report key: 2122735 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09952
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED ALTHOUGH A COMPLAINT HISTORY INDICATES THAT FAILURE IS PROBABLY VALID. THE LOT NUMBER INDICATES THE PRODUCT WAS MANUFACTURED IN 2005 AND IS SIX YEARS OLD. COMPLAINT SEARCH WAS COMPLETED AND FOUND SEVERAL PREVIOUS COMPLAINTS FOR THE HAMMER PAD BREAKING. THE ADDITION OF THIS COMPLAINT DOES NOT IMPACT THE TOTAL OCCURRENCE RATE IN (B)(4). THIS FAILURE MODE IS ALSO ADDRESSED AND DISCUSSED IN THE RISK MANAGEMENT REPORT, (B)(4). REVIEW OF THE INSPECTION RECORDS IN THE (B)(4) FOUND NO MANUFACTURING DEVIATIONS OR REJECTIONS. THE ROOT CAUSE IS ATTRIBUTED TO HEAVY USAGE AND WEAR OUT. THE RISK MANAGEMENT REPORT DISCUSSES THIS FAILURE MODE AND STATES THAT NO FURTHER ACTION IS REQUIRED. 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.

    Description of Event or Problem · 1

    DURING THE COURSE OF IMPLANTING THE VERSANAIL TTC NAIL INTO THE PT THE THREADED HAMMER PAD BROKE OFF AT THE NAIL/HAMMER PAD INTERFACE WHERE THE MOST DISTAL THREADS BROKE OFF IN THE PROXIMAL THREADED HEAD OF THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMMER PAD SMALL 87 LXH LXH DEPUY ORTHOPAEDICS, INC. NA ZG6CC4

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention