BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM HAND PLATE BENDER

    MDR report key: 7452544 · Received April 23, 2018

    Report

    Report Number
    0001825034-2018-02826
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    March 16, 2018
    Report Date
    July 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE - HXP. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS AND INSPECTION OF THE RETURNED DEVICE. THE FRACTURED TIP OF THE DEVICE WAS NOT RETURNED. HARDNESS DIMENSIONAL MEASUREMENT WAS PERFORMED AND WAS FOUND TO BE CONFORMING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE ANALYSIS INDICATED THAT THE DEVICE MET SPECIFICATION. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BENDER TIP BROKE OFF INTO THE FAST GUIDE DURING AN INITIAL PROCEDURE. THE TIP REMAINED IN THE FAST GUIDE WHICH WAS THEN REMOVED FROM THE PLATE. NO SERIOUS INJURY WAS CAUSED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294966 2.0MM HAND PLATE BENDER PLATE, FIXATION HRS ZIMMER BIOMET, INC. N/A 446741

    Patients

    Seq Age Sex Outcome Treatment
    1