BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM,SS 3.5X 14MMCORT

    MDR report key: 10108468 · Received June 2, 2020

    Report

    Report Number
    1220246-2020-01859
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    March 27, 2020
    Report Date
    June 2, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047280
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON 12/18/2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1, AR-8835-14 // LOT: 102663341 X 1, AR-8835-14 // LOT: 102688581 X 1, AR-8835-14 // LOT: 102732891 X 1, AR-8835-14 // LOT: 102915741 X 1, AR-8835-16 // LOT: 102211521 X 1, AR-8835-18 // LOT: 102111161 X 1, AR-8835-18 // LOT: 102230671 X 1, AR-8840-14 // LOT: 100357221 X 1. AT TIME OF INITIAL REPORT ON MARCH 9, 2020 OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED ON MARCH 20, 2020 THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/2020: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19 PANDEMIC. THE SALES REP HAS NOW BEEN ABLE TO CONFIRM THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 AT A DIFFERENT FACILITY. DURING THE REVISION ALL ORIGINAL IMPLANTS WERE EXPLANTED. REP WAS UNABLE TO CONFIRM IF THE PROCEDURE TOOK PLACE AT THE HEALTH SYSTEM¿S HOSPITAL OR THE OUTPATIENT SURGERY CENTER. THE FACILITY INFORMATION FOR THE HOSPITAL WILL THEREFORE BE USED. THERE IS NO INFORMATION PROVIDED REGARDING HOW THE CASE WAS COMPLETED ONCE THE BROKEN PLATE AND SCREWS WERE EXPLANTED. THE DISPOSITION OF THE EXPLANTED DEVICES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574485 LO-PRO SCRW TM,SS 3.5X 14MMCORT SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 14MMCORT 10266334 00888867047280

    Patients

    Seq Age Sex Outcome Treatment
    1 Other