BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM

    MDR report key: 19381087 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03716
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    November 23, 2022
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867233959
    PMA / PMN Number
    K051726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT IS NOT CONFIRMED. THREE UNPACKAGED, AND TWO PACKAGED AR-1547CDS BIOCOMPOSITE-TENODESIS SERIAL/BATCH NUMBER 13807670 WERE RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THREE RETURNED OPENED DEVICES WITH A MAGNIFIER DIDN'T FIND SHARP EDGES ON THE HEX DRIVER TIP. ONE OF THE ARRIVED PACKAGED DEVICES WAS OPENED AN OBSERVED UNDER THE MAGNIFIER AND DIDN'T FIND ANY SHARP EDGE ON THIS ONE EITHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TENDON REFIXATION SURGERY THE DRIVER OF THE DEVICE CUT OFF THE ASSOCIATED LOOP AT THE FRONT WITH THE METAL EDGE (FIBERWIRE LOOP). THIS HAPPENED TWICE IN ONE SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 13-JAN-2023 5 X AR-1547CDS WERE RECEIVED (3 X USED, 2 X ORIGINAL PACKED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219820 BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM 13807670 00888867233959

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown