BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 25MM

    MDR report key: 17666897 · Received August 31, 2023

    Report

    Report Number
    3000931034-2023-00278
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    May 15, 2023
    Report Date
    August 31, 2023
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    00846832092123
    PMA / PMN Number
    K161742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. 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. H3 OTHER TEXT: DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON DURING A PATIENTS PROCEDURE TRIED TO ENGAGE A 6.5 CENTER SCREW IN THE BASEPLATE. AS THE PHYSICIAN ENGAGED THE SCREW IT LOCKED ON THE INNER THREADS OF THE BASEPLATE AND SCREW COULD NO LONGER ADVANCE TO CORRECT LOCATION. SURGEON TRIED A DIFFERENT SCREW AND HAD SAME RESULTS. SURGEON THAN OPENED A NEW BASEPLATE AND WITH NO PROBLEMS THE SCREW PROPERLY ENGAGED THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513802 TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 25MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. 1756123 00846832092123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown