BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHROSCOPY PACK, COMPONENT WITHIN

    MDR report key: 1202791 · Received October 16, 2008

    Report

    Report Number
    1417592-2008-00034
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 14, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DURING AN ARTHROSCOPY PROCEDURE. THE PHYSICIAN WAS MAKING THE INITIAL PUNCTURE AND THE BLADE BROKE. THE BLADE WAS RETRIEVED WITH THE ASSISTANCE OF FLUOROSCOPY. NO FOREIGN OBJECT WAS OBSERVED ON FINAL X-RAY. THERE WAS NO INJURY TO THE PT. THE BLADE INVOLVED IN THE INCIDENT IS NOT A REINFORCED BLADE, WHICH IS WHAT THE FACILITY HAD PREVIOUSLY USED. THE FACILITY CONVERTED BACK TO THE USE OF REINFORCED BLADES FOR FUTURE SURGICAL CASES. A REINFORCED BLADE IS OFTEN PREFERRED FOR ORTHOPEDIC PROCEDURES, WHICH TYPICALLY INVOLVE MORE TORQUE ON THE BLADE. NO ADDITIONAL CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A SURGICAL BLADE BROKE DURING A SURGICAL PROCEDURE. THE BLADE WAS REMOVED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPY PACK, COMPONENT WITHIN SCALPEL BLADE, #11 LRP MEDLINE INDUSTRIES, INC. DYNJ30563 08ED3416

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention