BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE INSTRUMENTATION

    MDR report key: 8830948 · Received July 26, 2019

    Report

    Report Number
    8830948
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 2, 2019
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING A LEFT ROTATOR CUFF ARTHROPATHY UTILIZING ZIMMER BIOMET REVERSE SHOULDER SYSTEM, HUMERAL COMPONENT MICRO STEM, 10 MM POLYETHYLENE HUMERAL-BEARING SURFACE 36 MM +3, 36 GLENOSPHERE WITH BASEPLATE. WHEN THE TIP OF 2.7MM PERIPHERAL SCREW DRILL BIT (2 INCHES), STAINLESS STEEL, REF # (B)(4), LOT #073380, BROKE INSIDE OF BASE PLATE INFERIOR HOLE. ACCORDING TO REP, MATERIAL OF DRILL IS THE SAME AS THE SCREWS THAT IMPLANTED. IT WAS DECIDED TO LEAVE THE DRILL BIT IN BECAUSE IT WOULD HAVE BEEN MORE HARMFUL/CAUSED MORE DAMAGE TO REMOVE AND IT IS MADE OF THE SAME MATERIAL AS THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626261 COMPREHENSIVE INSTRUMENTATION BIT, DRILL HTW BIOMET ORTHOPEDICS, LLC 405889 073380

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA