BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS DIRECT CRESCENT XL

    MDR report key: 5994170 · Received October 3, 2016

    Report

    Report Number
    3006524618-2016-00264
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 12, 2016
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ACCU-PASS DIRECT CRESCENT XL DEVICE WAS USED FOR TREATMENT OF A LABRAL REPAIR. THE DEVICE WAS RECEIVED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. THE REPORTED DEVICE WAS RECEIVED AND ITS DISTAL END WAS FOUND BROKEN. NEEDLE CRESCENT BROKE OFF (NOT RETURNED) AND LEFT THE TUMBLE FLAT WIRE EXPOSED. FUNCTIONAL TEST CANNOT BE PERFORMED AS THE ACCU-PASS DEVICE IS A SINGLE USE DEVICE. PER INFORMATION PROVIDED, THE SURGEON TRIED TO INSERT INTO A 3.0 OUTFLOW CANNULA AGAINST THE REPRESENTATIVE'S ADVICE AND BY THE TIME THE SURGEON GOT TO THE TISSUE AND ATTEMPTED TO TRY AND INSERT IT, THE DEVICE BENT. THE SURGEON WAS ABLE TO PULL THE DEVICE OUT. BASED ON COMPLAINT INFORMATION AND OUR VISUAL INSPECTION, THE NEEDLE BROKE OFF DUE TO PASSING THRU A SMALLER CANNULA. PASSING THE DEVICE THRU A SMALLER CANNULA CAN ADD ADDITIONAL FORCE TO PASS THRU FORCING THE DEVICE TO BEND AND BREAK. INSTRUCTIONS FOR USE WERE REVIEWED AND THE CANNULA SIZE, IF USED, SHOULD BE A MINIMUM OF 5.0MM. CUSTOMERS COMPLAINT WAS CONFIRMED AND ROOT CAUSE BASED ON OUR VISUAL INSPECTION AND COMPLAINT INFORMATION IS DUE TO ABNORMAL USE. FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDES: (1) INCORRECT CANNULA USED. THE INSTRUCTION FOR USE (IFU) OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING AN ACCU-PASS DIRECT CRESCENT XL, THE SURGEON TRIED TO INSERT INTO A 3.0 OUTFLOW CANNULA AGAINST SUGGESTED USE, CAUSING THE DEVICE TO BEND. THE PROCEDURE WAS COMPLETED USING A COMPETITIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644724 ACCU-PASS DIRECT CRESCENT XL ACCESSORIES,ARTHROSCOPIC NBH ARTHROCARE CORP. 1144234

    Patients

    Seq Age Sex Outcome Treatment
    1