BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIST FUSION SYSTEM

    MDR report key: 17605200 · Received August 22, 2023

    Report

    Report Number
    MW5144876
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 10, 2023
    Report Date
    August 21, 2023
    Manufacturer
    STRYKER CORP./HOWMEDICA OSTEONICS CORP
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SURGEON WAS REMOVING SKELETAL DYNAMICS PLATE FROM A WRIST ON (B)(6)2023. SURGEON ATTEMPTED TO USE OUR SCREW REMOVAL SET TO REMOVE THE PLATE. AT SOME POINT, A SMALL CRUCIFORM SCREW BROKE WHILE TRYING TO REMOVE A SCREW. THE PLATE HAD TO BE CUT WITH A BURR ALSO BECAUSE THE SURGEON DID NOT HAVE THE PROPER EQUIPMENT FROM SKELETAL DYNAMICS TO REMOVE THEIR PLATE. THIS COMPLAINT INVOLVES TWO(2) DEVICES. REFERENCE REPORT: MW5144877. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286424 WRIST FUSION SYSTEM PLATE, FIXATION, BONE HRS STRYKER CORP./HOWMEDICA OSTEONICS CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SKELETAL DYNAMICS PLATE