BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK

    MDR report key: 13054598 · Received December 21, 2021

    Report

    Report Number
    1220246-2021-04150
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 1, 2021
    Report Date
    January 14, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023246
    PMA / PMN Number
    K101679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE DEVICE WAS RETURNED WITH THE ANCHOR AND EYELET ASSEMBLED. THE ANCHOR WAS FOUND TO BE BROKEN AND NO FRAGMENT WAS RETURNED. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER A LIKELY CAUSE IS PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A STABILIZATION SURGERY THE DEVICE BROKE DURING IMPLANTATION. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 07-DEZ-2021: IT WAS CONFIRMED THAT THE INTERFERENCE SCREW OF THE DEVICE BROKE DURING IMPLANTATION OF THE DEVICE AND ALL FRAGMENTS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948206 SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK 12777491 00888867023246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown