BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE ANCHOR, MICRO CORKSCREW FT

    MDR report key: 19201710 · Received April 29, 2024

    Report

    Report Number
    1220246-2024-02540
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    August 12, 2022
    Report Date
    April 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867008519
    PMA / PMN Number
    K112237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 (B)(6) 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 NOT CONFIRMED. UPON VISUAL INVESTIGATION IT WAS NOTED THAT THE ANCHOR WAS RECEIVED DISASSEMBLED FROM THE DRIVER. IT WAS ALSO NOTED THAT THE DEVICE WAS DISASSEMBLED FROM THE INNER PORTION OF THE DEVICE. THE O-RING WAS NOT RETURNED FOR INVESTIGATION. IT WAS ALSO NOTED THE TIP OF THE DRIVER WAS DAMAGED. DUE TO THE UNPACKAGED STATE OF THE DEVICE, THE AS RECEIVED CONDITION COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1318FT SUTURE ANCHOR HAD AN ISSUE. DURING A HAND AND WRIST PROCEDURE FOR A MEDI CARPAL FRACTURE ON (B)(6) 2022, WHEN THE SCRUB LOOKED AT THE IMPLANT AFTER HAVING OPENED THE PACKAGE ON THE BACK TABLE, THE ANCHOR TIP HAD COME OUT OF THE DRIVER AND COULD NOT BE LOADED BACK ONTO THE DRIVER, THE DEVICE WAS DAMAGED OUT-OF-BOX. NOTHING BROKE OFF INSIDE THE PATIENT, IT ALL OCCURRED ON THE BACK TABLE. THEY OPENED A NEW AR-1318FT SUTURE ANCHOR WITH THE SAME LOT NUMBER TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421488 SUTURE ANCHOR, MICRO CORKSCREW FT BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT 10232303 00888867008519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown