BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER

    MDR report key: 20451632 · Received October 15, 2024

    Report

    Report Number
    1421101-2024-00005
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Report Date
    October 10, 2024
    Manufacturer
    AVALIGN TECHNOLOGIES INC.
    Product Code
    DWS
    UDI-DI
    10885403023705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS INDICATED, DURING THE INSPECTION OF THE RETURNED INSTRUMENT, IT WAS IDENTIFIED THAT THE ITEM HAD BEEN USED AND STERILIZED SEVERAL TIMES AND DISPLAYED SIGNS OF POOR MAINTENANCE AND POSSIBLE MISUSE. THE MISUSE OF THE INSTRUMENT, SUCH AS TWISTING, PRYING, PUSHING, OR OTHER MEANS OF APPLYING FORCE, IMPROPER MAINTENANCE OR EXTENDED USE MAY HAVE CONTRIBUTED TO THE DAMAGE TO THE INSTRUMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, AVALIGN GSI QUALITY RECEIVED A CUSTOMER COMPLAINT FROM STERIS. STERIS REPORTED THAT THEY RECEIVED A COMPLAINT FROM THE HOSPITAL STATING, PRODUCT SNAPPED IN HALF OVER PATIENT ON TABLE DURING HEART PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36959 V. MUELLER V. MUELLER TITANIUM ANKENEY STERNAL RETR BLADE 1-1/4 X1-3/8 INCHES 3.2 X3.5CM DWS AVALIGN TECHNOLOGIES INC. CH1290 C24VIN 10885403023705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other