BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 19785598 · Received July 19, 2024

    Report

    Report Number
    1644408-2024-01085
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 20, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    UDI-DI
    00888912144391
    PMA / PMN Number
    K112069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED "3 HOLE GUIDE SCREW INTO TRUNION. BASEPLATE WOULD NOT ACCEPT GLENOSPHERE LOCKING SCREW." THIS EVENT OCCURRED DURING TREATMENT, NEAR THE PATIENT. NO RISK OR ADVERSE EVENT WAS REPORTED BY THE SURGEON. THERE WAS A 30 MINUTE DELAY IN SURGERY, BUT THE SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND TO BE ACCEPTABLE. THE AGENT WAS PRESENT WHEN THIS EVENT OCCURRED AND WAS ABLE TO PROVIDE ANOTHER SUITABLE DEVICE. THE REPORTED DEVICE WAS RETURNED TO SURGICAL FOR EVALUATION. THERE IS A BURR THAT IS PRESENT ON THE THREAD A REVIEW OF THE DEVICE HISTORY RECORD SHOW THAT THE REPORTED COMPONENT USED IN THE SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE 4 PARTS SCRAPPED AT OP 20 FOR MACHINING THE HOLES AND THREAD. THEY WERE SCRAPPED FOR VOIDS IN POROUS COATING AND WERE NOT RELATED TO THE THREADS. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS. COMPLAINT DATABASE REVIEW SHOWED NO PREVIOUS COMPLAINTS THAT ALLEGE THIS SAME ISSUE. THERE WERE NO OTHER COMPLAINTS AGAINST THE REPORTED LOT NUMBER. INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY DUE TO THE INSTRUMENT NOT PROPERLY ENGAGING THE THREADS RESULTING IN THE BURR BEING GENERATED. IT IS DIFFICULT TO DETERMINE IF THE BURR WAS PRESENT PRIOR SINCE THE AGENT STATED THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 0

    COMPLAINT - 3 HOLE GUIDE SCREW INTO TRUNION. BASEPLATE WOULD NOT ACCEPT GLENOSPHERE LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032642 DJO SURGICAL RSP BASEPLATE, 30MM, W/P2 COATING KWS ENCORE MEDICAL L.P. 76983263 00888912144391

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other