BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOHMANN RETRACTOR

    MDR report key: 10958502 · Received December 4, 2020

    Report

    Report Number
    MW5098223
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 2, 2020
    Manufacturer
    DEPUY SYNTHES, INC
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    DURING TOTAL SHOULDER RESURFACING SURGERY, THE HOHMANN RETRACTOR CAT # 03.100.110 LOT 6714770 BROKE AND THE TIP WAS LODGED IN THE PATIENT'S RIGHT PROXIMAL HUMERUS. SURGEON ATTEMPTED TO RETRIEVE MULTIPLE TIMES UNDER FLUOROSCOPY. DECIDED TO LEAVE THE STAINLESS-STEEL BROKEN TIP IN PLACE TO MAINTAIN THE INTEGRITY OF HUMERUS. SURGERY COMPLETED AS PLANNED WITH NO ADDITIONAL INTERVENTIONS. PATIENT WAS INFORMED AND LOCAL DEPT OF PUBLIC HEALTH NOTIFIED. PATIENT IS DOING WELL WITH FULL RANGE OF MOTION. DEPUY SYNTHES REP NOTIFIED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415209 HOHMANN RETRACTOR RETRACTOR GAD DEPUY SYNTHES, INC 6718770

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR