BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HNM LATERAL ANCHOR

    MDR report key: 7432662 · Received April 16, 2018

    Report

    Report Number
    3005031118-2018-00001
    Event Type
    Injury
    Date Received
    April 16, 2018
    Date of Event
    April 6, 2018
    Report Date
    April 12, 2018
    Manufacturer
    HNM STAINLESS, LLC DBA HNM MEDICAL
    Product Code
    HWC
    PMA / PMN Number
    K133036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE, REF HNM-79-5520 (LOT 2392) IS AN IMPLANTABLE LATERAL ANCHOR FOR FOOT AND ANKLE PROCEDURES. THIS DEVICE IS MANUFACTURED BY VALERIS MEDICAL, INC. UNDER 510(K) K133036 AND PRIVATE LABELED FOR HNM MEDICAL. A PACKAGED AND LABELED SAMPLE OF THE ANCHOR WAS MADE ON 11/30/2017 AND SENT TO HNM MEDICAL AS A DEMONSTRATION UNIT THE SAMPLE WAS MARKED AS NON-STERILE AND HAD A FICTIOUS EXPIRATION DATE OF 11/29/1993 TO ENSURE THAT IT WAS NOT USED FOR CLINICAL USE. THE DEVICE ITSELF WAS MADE TO SPECIFICATION, BUT WAS A NON-STERILE SAMPLE. THE SAMPLE DEVICE WAS INADVERTENTLY TAKEN TO THE SURGERY CENTER AND USED IN A PROCEDURE. DURING THE PROCEDURE IT WAS NOT NOTICED THAT THE PRODUCT LABEL STATED THAT IT WAS NON-STERILE AND THAT IT HAD PAST THE EXPIRATION DATE. ALTHOUGH THE SAMPLE DEVICE WAS USED DURING THE PROCEDURE, IT IS NOT KNOWN IF IT WAS ACTUALLY IMPLANTED, AS SEVERAL ANCHORS WERE TRIED AND DISCARDED DURING THE PROCEDURE. AS SOON AS HNM MEDICAL DISCOVERED THAT THE NON-STERILE SAMPLE WAS USED, THE PHYSICIAN AND SURGERY CENTER WAS NOTIFIED. SURGEON HAS RESPONDED THAT PATIENT IS DOING FINE AND TO THE BEST OF HNM'S KNOWLEDGE, NO SUPPLEMENTAL TREATMENT IS BEING DONE. WE HAVE CONFIRMED THAT ONLY ONE (1) NON-STERILE UNIT LEFT OUR FACILITY AND THAT THERE ARE NO MORE IN THE FIELD.

    Description of Event or Problem · 1

    DURING A FOOT AND ANKLE PROCEDURE ON (B)(6) 2018, A NON-STERILE LATERAL ANCHOR WAS USED AND POSSIBLY IMPLANTED INTO A PATIENT. THE SURGEON AND SURGERY CENTER WAS NOTIFIED ON 4/9/2018. THE PATIENT IS DOING FINE AND TO THE BEST OF OUR KNOWLEDGE, NO ADDITIONAL TREATMENT IS BEING DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276499 HNM LATERAL ANCHOR SCREW, FIXATION, BONE HWC HNM STAINLESS, LLC DBA HNM MEDICAL HNM-79-5520 2392

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization