BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 SHOULDER PLATE 11 HOLE RIGHT

    MDR report key: 2110030 · Received May 17, 2011

    Report

    Report Number
    1818910-2011-08800
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXT
    PMA / PMN Number
    K060290
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED FOR THE PLATE AND THE PART/LOT CODES REQUIRED FOR THE SCREWS WERE NOT PROVIDED. A PREVIOUS INVESTIGATION FOUND ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, THERE ARE PREVIOUS COMPLAINTS FOR THIS FAILURE MODE. PT ANATOMY AND SURGICAL TECHNIQUE CAN IMPACT THE PEG ENGAGEMENT EVEN IF THE PRODUCT IS WITHIN SPEC. THIS IS DISCUSSED IN DVA-104443-DFMEA AND DVA-10443-RMR AND IS APPROVED WITH AN IFR (INVESTIGATE FURTHER REDUCTION) DESIGNATION. THE ENGAGEMENT ISSUES ARE IMPACTED BY PT ANATOMY AND SURGICAL TECHNIQUE. ALTHOUGH THE RISK IS CONSIDERED ACCEPTABLE PER THE RMR (RISK MANAGEMENT REPORT), PRODUCT DEVELOPMENT, QUALITY AND MARKETING ARE INVESTIGATION WAYS TO FURTHER REDUCE THE OCCURRENCE OF PEG ENGAGEMENT ISSUES. (B)(4) WAS OPENED ON (B)(4) 2011 TO DETERMINE IF ANY ADD'L ACTIONS MAY DECREASE THE LIKELIHOOD OF PEG ENGAGEMENT ISSUES. ANY ROOT CAUSE AND/OR CORRECTIVE ACTIONS WILL BE DOCUMENTED IN (B)(4). DEPUY 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

    SCREWS WOULD NOT LOCK INTO THE PLATE. THIS RESULTED IN A SURGICAL DELAY OF 30-45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 SHOULDER PLATE 11 HOLE RIGHT 87 LXT LXT DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR