BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG STANDARD 4.0X50.0MM

    MDR report key: 2183513 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-10159
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 26, 2011
    Manufacturer
    DEPUY ACE S.A.'R.L.
    Product Code
    LXT
    PMA / PMN Number
    K060290
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 CODES REQUIRED WERE NOT PROVIDED. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, THERE ARE PREVIOUS COMPLAINTS FOR THIS FAILURE MODE. PATIENT ANATOMY AND SURGICAL TECHNIQUE CAN IMPACT THE PEG ENGAGEMENT EVEN IF THE PRODUCT IS WITHIN SPECIFICATION. THIS IS DISCUSSED IN (B)(4) AND IS APPROVED WITH AN IFR (INVESTIGATE FURTHER REDUCTION) DESIGNATION. THE ENGAGEMENT ISSUES ARE IMPACTED BY PATIENT ANATOMY AND SURGICAL TECHNIQUE. ALTHOUGH THE RISK IS CONSIDERED ACCEPTABLE PER THE RMR (RISK MANAGEMENT REPORT), PRODUCT DEVELOPMENT, QUALITY AND MARKETING ARE INVESTIGATING WAYS TO FURTHER REDUCE THE OCCURRENCE OF PEG ENGAGEMENT ISSUES. (B)(4) WAS OPENED ON (B)(4) 2011, TO DETERMINE IF ANY ADDITIONAL 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 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

    PEGS WOULD NOT LOCK INTO THE PLATE WHEN ENGAGED, RESULTING IN THE PT BEING RETURNED TO THEATRE THE NEXT DAY, FOR THE REMOVAL AND REPLACEMENT OF PRODUCTS BY ANOTHER COMPANY AND TO PREVENT ANY FURTHER DAMAGE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG STANDARD 4.0X50.0MM 87 LXT LXT DEPUY ACE S.A.'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA