BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 9248360 · Received October 28, 2019

    Report

    Report Number
    3006524618-2019-00528
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 2, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    MBI
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT CANNOT BE ESTABLISHED AS THE PRODUCT WAS NOT RETURNED. WITHOUT THE REPORTED PRODUCT A FULLY VISUAL AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER¿S COMPLAINT CANNOT BE CONFIRMED. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITHOUT EVALUATION OF THE DEVICE; HOWEVER, FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) EXCESSIVE FORCE (2) MISALIGNMENT OF INSERTER AND IMPLANT DURING AND AFTER INSERTION. THE INSTRUCTION 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 DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE 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 A RIGHT SHOULDER STABILISATION, A 2.8 MM Q-FIX ANCHOR FAILED; IT WAS IMPLANTED BUT PULLED OUT. A COMPETITOR ANCHOR WAS USED AND SUCCESSFULLY IMPLANTED. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039549 2.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORP. 2029068

    Patients

    Seq Age Sex Outcome Treatment
    1