BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE BLADE (H=75 MM)

    MDR report key: 4850294 · Received June 12, 2015

    Report

    Report Number
    3006639916-2015-00120
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 15, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BREAKAGE OF THE BLADE OF THE RETRACTOR DURING SURGERY (1 TOOTH BROKE OFF). THE INSTRUMENT WAS CONSISTENT VISUALLY PRIOR TO SURGERY. THE DISCREPANCY WAS NOTICED DURING SURGERY, DURING THE USE OF THE DEVICE. THE BROKEN PART WAS FOUND IN THE WOUND. SURGERY SUCCESSFULLY COMPLETED. REF MFR # 3005180920-2015-00120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383746 LARGE BLADE (H=75 MM) SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1213240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention