BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 3.5MM HEX DRIVE

    MDR report key: 10397016 · Received August 12, 2020

    Report

    Report Number
    0001825034-2020-03153
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 17, 2020
    Report Date
    October 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304484498
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE REPORTED EVENT. UPON VISUAL INSPECTION THE RETURNED DRIVER HAS CIRCULAR WEAR ON THE SHAFT AND FRACTURED AT THE TIP. THE DEVICE WAS SENT FOR SEM. SEM CONCLUDED THE DRIVER TIP FRACTURED ANGULARLY TO THE LONG AXIS. FRACTURE SURFACE ARTIFACTS SUGGEST A TORSIONAL OVERLOAD FRACTURE. XRF ANALYSIS FOUND THE HEX DRIVE MATERIAL TO BE CONSISTENT WITH 430/440 STAINLESS STEEL ALLOY. THE DEVICE WAS MANUFACTURED IN MAY 2017 AND HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 3 YEARS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. SEM ANALYSIS SUGGESTS TORSIONAL OVERLOAD AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT, HOWEVER 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 31-301301 ¿ ARCOS CONE ¿ 446954; 11-300915 ¿ARCOS DISTAL STEM ¿ 145630. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE TORQUE LIMITING DRIVER TIP SNAPPED OFF AND GOT STUCK INSIDE THE LOCKING MECHANISM OF THE CONE BODY TRIAL WHILE TRIALING THE CONE WITH THE DISTAL STEM. THE TRIAL CONE WAS UNABLE TO BE REMOVED FROM THE DISTAL IMPLANT SO IT WAS WASTED AND A DIFFERENT SIZED IMPLANT AND NON-TORQUE LIMITING DRIVER WERE USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861433 ARCOS 3.5MM HEX DRIVE HIP INSTRUMENT LZO ZIMMER BIOMET, INC. N/A ZB170201 00880304484498

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR