BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS NITINOL STAPLE SYSTEM

    MDR report key: 11600645 · Received April 1, 2021

    Report

    Report Number
    3008650117-2021-00078
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Report Date
    March 31, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    JDR
    PMA / PMN Number
    K170923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IDENTIFYING INFORMATION, SUCH AS THE PART NUMBER AND LOT NUMBER OF THE DEVICE WAS NOT REPORTED TO PARAGON 28. CASE INFORMATION INCLUDING FACILITY, SURGERY DATE(S), OR RELATED PATIENT INFORMATION WAS NOT PROVIDED BY THE INITIAL REPORTER. DEVICES ARE NOT EXPECTED TO BE RETURNED FOR THE MANUFACTURER REVIEW/INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    PARAGON 28 RECEIVED A REPORT ABOUT THE JAWS STAPLE SYSTEM. THE SURGEON BELIEVED THAT THE STAPLE ONLY GIVES COMPRESSION ON THE TIP OF THE STAPLE LEGS, RESULTING TO OPEN UP THE AKIN OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501384 JAWS NITINOL STAPLE SYSTEM STAPLE JDR PARAGON 28, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1