BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLX RMR 8.0MM DISP

    MDR report key: 7413090 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02268
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    January 16, 2018
    Report Date
    May 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 110004186, PRECISION FLX RMR 8.0 MM DISP, 002630. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO ADVANCE THE CANNULATED REAMER OVER THE GUIDE PIN THE REAMER WOULD NOT MOVE FORWARD AS SOMETHING WAS BLOCKING IT. AFTER A FEW ATTEMPTS, THE SURGEON REMOVED THE REAMER AND SAW THAT IT WAS BROKEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257110 PRECISION FLX RMR 8.0MM DISP REAMER HTO ZIMMER BIOMET, INC. N/A 585220

    Patients

    Seq Age Sex Outcome Treatment
    1