BEUDAMED
    FDA Adverse Event Other Summary report: N

    MANTA 1 UP CURVE

    MDR report key: 1393989 · Received May 27, 2009

    Report

    Report Number
    2951580-2009-00033
    Event Type
    Other
    Date Received
    May 27, 2009
    Date of Event
    April 21, 2009
    Report Date
    May 22, 2009
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT WAS NOT PROVIDED AN APPROXIMATE DATE WAS PROVIDED BY ARTHROCARE CORPORATION. THE PHYSICIAN INDICATED THAT NO FURTHER INFORMATION WILL BE PROVIDED FOR THIS REPORT. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY INSPECTED. THE VISUAL INSPECTION CONFIRM THE INNER TIP OF THE DEVICE HAD DETACHED. THE FUNCTIONAL INSPECTION CONFIRMED THE DEVICE WAS RETURNED IN A NONFUNCTIONAL CONDITION. THE ROOT CAUSE OF THE FAILURE WAS DETERMINED DUE TO MISUSE OF THE DEVICE.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING A MANTA 1 UP CURVE INSTRUMENT WAS REPORTED TO ARTHROCARE CORPORATION. IT WAS REPORTED THE FRONT PART OF THE PUNCH BROKE DURING USE WHILE CUTTING MENISCUS TISSUE. THE BROKEN PIECE WAS LEFT IN THE PATIENT . NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTA 1 UP CURVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROCARE CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other