BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 25MM

    MDR report key: 17750365 · Received September 14, 2023

    Report

    Report Number
    0001649390-2023-00234
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    May 3, 2023
    Report Date
    September 14, 2023
    Manufacturer
    TORNIER INC
    Product Code
    PHX
    UDI-DI
    00846832092123
    PMA / PMN Number
    K161742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. THE DEVICE WAS RETURNED FOR EVALUATION AND FOUND TO BE IN THE CONDITION NOTED IN THE EVENT DETAILS. VISUAL INSPECTION: A VISUAL INSPECTION REVEALED THE PART WAS ASSEMBLED INCORRECTLY. THE CORRECT LOCK SPACER FOR THIS ASSEMBLY SHOULD BE CD-6137-01 SIZE 3.5MM. IT WAS ASSEMBLED WITH LOCK SPACER CD-6137-02 SIZE 6MM. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON THE INVESTIGATION, THE EVENT INVOLVED A PRODUCT PROBLEM INDICATING A NON-CONFORMITY, ADVERSE TREND, OR UNANTICIPATED HAZARD DUE TO A MANUFACTURING ISSUE WHICH HAS BEEN ELEVATED TO AN NC TO INVESTIGATE FURTHER AND DETERMINE THE ROOT CAUSE OF THE EVENT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    THE PHYSICIAN ATTEMPTED TO INSERT THE CENTER SCREW INTO THE BASEPLATE, BUT IT WOULDN'T ADVANCE. TRYING A DIFFERENT SCREW HAD THE SAME RESULT. EVENTUALLY, A NEW BASEPLATE WAS USED, AND IT WORKED WITHOUT ANY ISSUES. THE PROCEDURE, WHICH INVOLVED REVERSE CENTRAL SCREW, PERIPHERAL SCREWS, AND GLENOSPHERE, WAS PLANNED WITH THE PROBLEMATIC BASEPLATE, BUT IT COULDN'T BE USED BECAUSE THE CENTRAL SCREW COULDN'T BE THREADED ALL THE WAY INTO THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903796 TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 25MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER INC 1756123008 00846832092123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown