BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE ANCHOR, BIO-CORKSCREW FT

    MDR report key: 17671162 · Received September 1, 2023

    Report

    Report Number
    1220246-2023-07762
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    March 13, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023352
    PMA / PMN Number
    K061863
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-1927BCF SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. AFTER VISUAL EVALUATION, IT WAS NOTED THAT THE BIO/IMPLANT SCREW ARRIVED DAMAGED/BROKEN, MISSING HALF OF THE IMPLANT. NO DAMAGE WAS OBSERVED ON THE SHAFT OR HANDLE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS USER ERROR. PER DFU-0087-EO REVISION 2. WARNINGS. 6. BIOABSORBABLE ONLY: ATTEMPTING IMPLANTATION INTO HARD, DENSE BONE AND/OR DRILLING/PUNCHING SMALLER DIAMETER HOLES THAN RECOMMENDED MAY CAUSE FAILURE (BREAKAGE) OF THE IMPLANT DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FUNCTION OF THE DEVICE DIDN`T RELEASE AFTER THREE TURNS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 15-MAR-2023: FURTHER INFORMATION WAS PROVIDED THAT NO PART OF THE DEVICE BROKE OFF. 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 30-AUG-2023: IT WAS CONFIRMED THAT THE SURGEON TURNED THE DEVICE TWICE AND ON THE THIRD TURN CAME THE CRACK AND THE BREAK. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390415 SUTURE ANCHOR, BIO-CORKSCREW FT BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT 10763039 00888867023352

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown