BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLENOID HEAD INSERTER

    MDR report key: 17550508 · Received August 14, 2023

    Report

    Report Number
    MW5144557
    Event Type
    Other
    Date Received
    August 14, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 9, 2023
    Manufacturer
    ENOVIS / ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON PLACED A SHOULDER IMPLANT AND STARTED HAVING DIFFICULTY GETTING THE SCREW IN PLACE. UPON INVESTIGATION BY THE SURGEON, FIRST ASSIST, AND VENDOR, IT WAS DISCOVERED THAT THE END OF THE T PIECE HANDLE (GLENOID HEAD INSERTER) WAS BROKEN OFF AND SCREWED DOWN INTO THE IMPLANT. THE SURGEON STATED THAT SINCE END OF PIECE WAS SCREWED INTO THE IMPLANT IT WOULD CAUSE MORE HARM TO TRY TO REMOVE IMPLANT AND PIECE OF T HANDLE. SURGEON STATED THAT HE WILL DISCLOSE WITH WIFE AFTER SURGERY. FOREIGN OBJECT TO REMAIN IN PATIENT INSTEAD OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528462 GLENOID HEAD INSERTER IMPACTOR HWA ENOVIS / ENCORE MEDICAL, L.P. 274186L02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other