BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 19672426 · Received July 3, 2024

    Report

    Report Number
    1644408-2024-01021
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 5, 2024
    Report Date
    December 10, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    FZX
    UDI-DI
    00888912148177
    PMA / PMN Number
    E529269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE D2, D3, D9, G1, H3, H6, AND H11. THE AGENT REPORTED THE 4 HOLE GUIDE WAS NOT SITTING FLUSH. THIS EVENT OCCURRED DURING TREATMENT NEAR THE PATIENT. HEALTHCARE PROFESSION INDICATED NO RISK OR ADVERSE OUTCOME WERE REPORTED BY THE SURGEON. THERE WAS A 20 MIN DELAY IN SURGERY AND THE SURGERY WAS COMPLETED AS INTENDED. THE INSTRUMENTS WERE INSPECTED PRIOR TO USE AND FOUND ACCEPTABLE. THE AGENT WAS PRESENT WHEN THIS EVENT OCCURRED AND DID PROVIDE ANOTHER SUITABLE DEVICE. THE REPORTED INSTRUMENT WAS RETURNED TO ENOVIS SURGICAL FOR EVALUATION. DURING THE INVESTIGATION IT WAS FOUND THAT THE INSTRUMENT WAS SITTING FLUSH, COULD HAVE BEEN TISSUE STUCK IN BETWEEN TO MAKE THE DEVICE NOT SIT FLUSH AT THE TIME. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORDS (DHR) REVEALED, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NCMRS ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENT THAT IS RELATED TO THE REPORTED ISSUE. THE ROOT CAUSE OF THIS COMPLAINT WAS NO DEFECT FOUND AND AT THIS TIME THE DEVICE IS DEEMED ACCEPTABLE. COMPLAINT DATABASE REVIEW SHOWED NO PREVIOUS COMPLAINTS THAT ALLEGE THIS SAME ISSUE. THERE ARE NO INDICATIONS THAT THE INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PRIMARY SURGERY: BASEPLATE WOULD NOT ACCEPT GLENOSPHERE LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571953 DJO SURGICAL DRILL GUIDE, TWO PIECE, RSP FZX ENCORE MEDICAL L.P. UNKNOWN 00888912148177

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other