BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX SHOULDER SYSTEM REVERSED

    MDR report key: 12779125 · Received November 9, 2021

    Report

    Report Number
    3000931034-2021-00054
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 18, 2021
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386941054
    PMA / PMN Number
    K122698
    Removal / Correction Number
    FA- WMG-2021-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RELATED TO VOLUNTARY RECALL FA- WMG-2021-005 FOR PRODUCT MIX. DURING REASSESSMENT OF THE REPORTED EVENT AFTER HEALTH HAZARD EVALUATION ASSESSMENT WAS CONCLUDED THE REPORTABILITY DECISION WAS REVISED TO BE REPORTED UNDER THE VIGILANCE PROCESS WITH THE AWARENESS DATE OF OCTOBER-14-2021. ALL AFFECTED PARTS WERE RECALLED. 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. THE ROOT CAUSE IS ATTRIBUTED TO A MANUFACTURING DEFECT (HUMAN ERROR DURING A PACKAGING STEP).

    Description of Event or Problem · 0

    DISCREPANCY BETWEEN THE IMPLANT LABEL NOTED (ECCENTERED) ON THE PACKAGING AND THE IMPLANT INSIDE (CENTERED). OPENING OF ANOTHER IMPLANT. NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682234 FLEX SHOULDER SYSTEM REVERSED PROSTHESIS SHOULDER METAL KWS TORNIER S.A.S. TRAY DIA. 40 TH 0 ECC 1.5 1197AW 03700386941054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other