BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM 2 KNOTLESS IMPLANT

    MDR report key: 8518639 · Received April 16, 2019

    Report

    Report Number
    3006524618-2019-00188
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    April 2, 2019
    Report Date
    July 8, 2019
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    MBI
    UDI-DI
    00817470005486
    PMA / PMN Number
    K042914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    C-0241370 THE RETURNED DEVICES, INTENDED FOR USE IN TREATMENT, WERE RETURNED AN MDR¿S FOR EVALUATION.THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICES AND THE REPORTED INCIDENT.VISUAL INSPECTION OF THE RETURNED MAGNUM2 KNOTLESS IMPLANT OM-1502 SHOWS DEPLOYED INSTRUMENT. THE IMPLANTS AT DISTAL END WERE DETACHED ON BOTH INSTRUMENTS AND NOT RETURNED WITH THE DEVICES. THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED WITH THE RETURNED INSTRUMENTS.THE MAGNUM2 IS A SINGLE USE DEVICE AND COULD NOT BE FUNCTIONAL TESTED. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. THE INSTRUMENTS WERE DAMAGED WITH MISSING PARTS AND ON DEVICE #1 MISSING SCREWS. THIS INSTRUMENT WAS OPENED. ALL MISSING PARTS WERE NOT RETURNED WITH THE DEVICES. FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDES: (1) IMPROPER SUTURE LOADING, (2) EXCESSIVE TENSIONING/FORCES OR (3) IMPROPER ALIGNMENT OF THE INSERTER HANDLE WITH THE BONE HOLE. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO OUTLINE 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.C-00241000 THE RETURNED DEVICES, INTENDED FOR USE IN TREATMENT, WERE RETURNED AS AN MDR¿S FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICES AND THE REPORTED INCIDENT. THE COMPLAINT WAS NOT VERIFIED, BUT THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY AS THE PRODUCTS ARE IN ITS ORIGINAL STATE AND THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICES DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SPRING FAILED AND POPPED OUT IN ANCHOR DEPLOYMENT. SUTURES WERE UNABLE TO BE TENSIONED; THEREFORE, THE FAULTY ANCHORS REMAIN STUCK IN PATIENT. A FURTHER ANCHOR OF SAME LOT WAS ATTEMPTED AND SAME FAILURE REPEATED. ADDITIONAL BONE HOLES WERE REQUIRED TO INSERT THE OTHER ANCHORS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH USE OF SAME ANCHOR, BUT FROM DIFFERENT LOT NUMBER WITHOUT A CONSIDERABLE DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314407 MAGNUM 2 KNOTLESS IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORP. 2024262 00817470005486

    Patients

    Seq Age Sex Outcome Treatment
    1