BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-DRIVE DISK DRILL

    MDR report key: 8152576 · Received December 11, 2018

    Report

    Report Number
    0001825034-2018-11213
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 10, 2018
    Report Date
    February 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDX
    PMA / PMN Number
    K031280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 423871 ULTRA DRIVE DISK DRILL, 186730. 423838 ULTRA DRIVE TIP EXTENDER, 688070. 423836 ULTRA DRIVE TIP EXTENDER, 434510. 423872 ULTRA DRIVE DISK DRILL, 112350. 423874 ULTRA DRIVE DISK DRILL, 716550. 423836 ULTRA DRIVE TIP EXTENDER, 123460.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY THE INSTRUMENT BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993204 ULTRA-DRIVE DISK DRILL INSTRUMENT, HIP JDX ZIMMER BIOMET, INC. N/A 078290

    Patients

    Seq Age Sex Outcome Treatment
    1