BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC U PLUS

    MDR report key: 8085327 · Received November 19, 2018

    Report

    Report Number
    3005670412-2018-00010
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 29, 2018
    Report Date
    October 30, 2018
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    HRS
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCATION AT WHICH THE BREAK OCCURRED IS THE WEAKEST SECTION OF THE GUIDE. THE BROKEN SURFACE IS ROUGH IN TEXTURE WHICH IS INDICATIVE OF A SINGLE OVERLOAD EVENT THAT HAS A HIGH ENOUGH LOAD TO BREAK THE PART. THE BREAK IS A BRITTLE FRACTURE WHERE THERE ARE ENOUGH GEOMETRY CHANGES IN THE PART TO CREATE A STRESS CONCENTRATION. THERE DOES NOT APPEAR TO BE ANYTHING ELSE WRONG WITH THE GUIDE.

    Description of Event or Problem · 1

    DURING THE CASE, THE SURGEON WAS TRYING TO COMPRESS THE U PLUS 90 GUIDE WITH THE DRIVER. HE WAS HAVING A HARD TIME GETTING THE GUIDE TO COMPRESS AND THEN THE GUIDE SNAPPED AND PART OF THE GUIDE FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE AND WHEN HE ACCESSED THE PLATE ON THE RIB, HE REALIZED THAT THE WEBS DID NOT COMPRESS. IT TOOK ABOUT 20 MINUTES TO RETRIEVE THE BROKEN PIECE. IT FELL IN THE CHEST CAVITY BUT THE PATIENT HAD A THORACOTOMY DONE AND THE SURGEON THAT HAD DONE THAT PROCEDURE WAS ABLE TO REACH IN THROUGH THE PORT AND RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927213 RIBLOC U PLUS PRIMARY GUIDE, LOW PROFILE HRS ACUTE INNOVATIONS LLC RBL2320 L1702001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization