BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 3.5MM HEX DRIVE

    MDR report key: 7369066 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02034
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    July 29, 2016
    Report Date
    July 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 22-300920, ARCOS 20X190MM SPL TPR DIST HA, 364250, 31-301303, ARCOS CON SZ C STD 60MM TRL, 242320. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION SHOWS FRACTURED PORTION OF THE DRIVER IS LODGED INSIDE THE TRIAL.THE INSTRUMENT HAS NUMEROUS SCRATCHES, DENTS & OTHER SIGNS OF WEAR. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 DURING A HIP PROCEDURE WHILE THE SURGEON WAS TRYING TO UNSCREW THE TRIAL BODY FROM THE DISTAL STEM, THE SCREWDRIVER TIP BROKE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213446 ARCOS 3.5MM HEX DRIVE PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A ZB160309

    Patients

    Seq Age Sex Outcome Treatment
    1