BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL

    MDR report key: 12897327 · Received November 30, 2021

    Report

    Report Number
    1220246-2021-04026
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 12, 2021
    Report Date
    November 30, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313231
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    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.

    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

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-08, AN AR-18716-09, AND AN AR-18716-11 CORTICAL SCREWS BROKE ON THE FILE TIGHTENING OF THE SCREW. THIS WAS DISCOVERED DURING A PROCEDURE, THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED. AFTER RECEIVING ADDITIONAL INFORMATION ON (B)(6) 2021, SALES REPRESENTATIVE HAS CONFIRMED THAT DURING THE METACARPAL FRACTURE PROCEDURE, THREE CORTICAL SCREW BROKE AND REMAINED IN PATIENT. SURGEON USED A 1.2MM DRILL BIT TO PREPARE BONE TUNNELS AND PUT IN NEW SCREWS IN OTHER HOLES OF THE PLATE.

    Description of Event or Problem · 0

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-08, AN AR-18716-09, AND AN AR-18716-11 CORTICAL SCREWS BROKE ON THE FILE TIGHTENING OF THE SCREW. THIS WAS DISCOVERED DURING A PROCEDURE, THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED. AFTER RECEIVING ADDITIONAL INFORMATION ON (B)(6) 2021, SALES REPRESENTATIVE HAS CONFIRMED THAT DURING THE METACARPAL FRACTURE PROCEDURE, THREE CORTICAL SCREW BROKE AND REMAINED IN PATIENT. SURGEON USED A 1.2MM DRILL BIT TO PREPARE BONE TUNNELS AND PUT IN NEW SCREWS IN OTHER HOLES OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800071 LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL PLATE, FIXATION, BONE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL 00888867313231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown