BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET

    MDR report key: 13048760 · Received December 20, 2021

    Report

    Report Number
    3000931034-2021-00354
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 25, 2021
    Report Date
    December 20, 2021
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386941030
    PMA / PMN Number
    K122698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS CONDUCTED AND CONFIRMED THAT TWO SPECIFIC LOTS OF FLEX REVERSED TRAY HAVE BEEN SWAPPED AND CONTAIN THE INCORRECT PRODUCT IN THE PACKAGE : AEQUALIS ASCEND FLEX REVERSED TRAY (+)0 THICKNESS, 1.5MM OFFSET, REFERENCE DWF510, LOT 1197AW AND AEQUALIS ASCEND FLEX REVERSED TRAY (+)0 THICKNESS, 0.0MM OFFSET, REFERENCE DWF500, LOT 1179AW A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. THE AFFECTED PARTS WERE RECALLED. THIS EVENT IS RELATED TO VOLUNTARY RECALL FA- WMG-2021-005 FOR PRODUCT MIX. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 0

    TODAY I HAD A WRONG IMPLANT IN A PACKAGE. THE PACKAGE INDICATED DWF510 AND IT SEEMED TO HAVE A DWF500 IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947551 TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S. DWF500 1197AW 03700386941030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other