BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG HP PATELLA & INSERTION CSE

    MDR report key: 6058057 · Received October 26, 2016

    Report

    Report Number
    1818910-2016-30227
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 29, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE SUBMITTED INSTRUMENT CASES CONFIRMED THE BRACKETS ARE DELAMINATING. A SEARCH OF THE COMPLAINT DATABASE FOUND ADDITIONAL REPORTS OF BRACKET DELAMINATION FOR SIGMA HP INSTRUMENT CASES AGAINST THE COMPLAINT SAMPLE PRODUCT CODES. PREVIOUS INVESTIGATION DID NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE, ALTHOUGH IT IS THE SUPPLIER MANUFACTURING PROCESS RELATED. DETAILS OF THIS ISSUE HAVE BEEN DOCUMENTED THROUGH PRA / HHE (DVA- (B)(4)) AND CAPA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PLASTIC COATING PEELING OFF THE SIGMA HP INSTRUMENT TRAYS FROM REPEATED WASH/STERILIZATION PROCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708172 SIG HP PATELLA & INSERTION CSE KNEE INSTRUMENT/TRIAL FSM DEPUY ORTHOPAEDICS, INC. DV3BF4

    Patients

    Seq Age Sex Outcome Treatment
    1