BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 8881604 · Received August 10, 2019

    Report

    Report Number
    3006524618-2019-00383
    Event Type
    Malfunction
    Date Received
    August 10, 2019
    Date of Event
    July 29, 2019
    Report Date
    September 25, 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 2.8MM Q FIX ALL SUTURE ANCHOR 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 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 (3) BONE HOLE SIZE. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW 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 THE SURGERY DR LOW FOLLOWED THE CORRECT SURGICAL TECHNIQUE FOR INSERTING A 2.8 MM Q-FIX AS HE TURNED THE HANDLE TO DEPLOY THE ANCHOR, IT DID NOT DEPLOY AND GOT STUCK IN THE ANCHOR SHAFT MAKING IT UNABLE TO BE USED. AN ADDITIONAL BONE HOLE WAS CREATED. WE OPENED A NEW ONE AND USING THE SAME TECHNIQUE DEPLOYED THE Q-FIX WITHOUT ANY ISSUES, NO COMPETITOR COMPANY WAS USED AND NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675595 2.8MM Q-FIX ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORP. 2030050

    Patients

    Seq Age Sex Outcome Treatment
    1