BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRASPER, ALLIGATOR MAX

    MDR report key: 4123561 · Received September 26, 2014

    Report

    Report Number
    1020279-2014-00593
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 19, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY WAS EXTENDED GREATER THAN 30 MINUTES.

    Description of Event or Problem · 1

    THE TIP END OF THE PUNCH BROKE DURING SURGERY MENISCECTOMY. THE METALLIC PIECE COULD NOT BE REMOVED AND REMAINED IN THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600280 GRASPER, ALLIGATOR MAX ARTHROSCOPE AND ACCESSORIES HRX SMITH & NEPHEW, INC. 011024 1798

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R