BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S35 SIZER

    MDR report key: 14164496 · Received April 20, 2022

    Report

    Report Number
    3000931034-2022-00197
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 23, 2022
    Report Date
    April 20, 2022
    Manufacturer
    TORNIER S.A.S.
    Product Code
    LXH
    UDI-DI
    03700386972898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION WAS PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED, AND NO OTHER EVIDENCE WAS PROVIDED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN-RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714715 S35 SIZER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH TORNIER S.A.S. 13B324 03700386972898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown