BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERTUBE SYSTEM

    MDR report key: 11758498 · Received April 30, 2021

    Report

    Report Number
    3008650117-2021-00088
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 30, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HTY
    PMA / PMN Number
    K171715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF ANY IMPLANT FAILURE AND THE IMPLANT IS STILL IN THE PATIENT. DEVICE HISTORY RECORD WAS NOT REVIEWED BECAUSE THE IMPLANT LOT NUMBER WAS NOT REPORTED. THE CLINICAL IMAGE SHOWS A 2ND DIGIT WITH EDEMA AND MILD ERYTHEMA. THE RADIOGRAPHIC IMAGES SHOW AN OBLIQUE AND AP VIEW OF THE SECOND DIGIT WITH A HAMMERTUBE IMPLANT IN POSITION ACCORDING TO THE SURGICAL TECHNIQUE GUIDE. FUSION ACROSS THE PIPJ IS DIFFICULT TO ASSESS FROM THE PROVIDED IMAGES, AND MUST BE CLINICALLY CORRELATED. GOOD ALIGNMENT AND BONE APPOSITION ACROSS THE PIPJ OF THE 2ND DIGIT IS APPRECIATED. 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

    PATIENT REACTION: SWELLING AND SKIN IRRITATION OF THE SECOND PHALANX WAS REPORTED. THE ORIGINAL SURGERY WAS (B)(6) 2021 WHERE SAME DEVICE WAS USED ON BOTH FEET. NO SWELLING ON THE LEFT FOOT. NO ALLEGE DEFICIENCY OF PRODUCT. ANTIBIOTICS WAS SAID TO NOT HAVE HELPED. THE SURGEON DECIDED TO LEAVE THE IMPLANT IN AND RE-EVALUATED IN 8 WEEKS AND COMPLETE A CULTURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651384 HAMMERTUBE SYSTEM HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED (STERILE) HTY PARAGON 28, INC. P40-002-0275-S

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR