BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 3.5MM HEX DRIVE

    MDR report key: 15561049 · Received October 7, 2022

    Report

    Report Number
    0001825034-2022-02288
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4; B5; D10; G3; H2; H3; H4; H6. D10: CAT #: 31-301355/ ARCOS CON SZ E HI 80MM TRL/ LOT #:761320. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE TIP OF THE HEX DRIVER HAD FRACTURED INSIDE OF THE TRIAL BODY. THERE ARE WEAR LINES ON THE SHAFT OF THE DRIVER. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED 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 · 0

    IT WAS REPORTED THAT WHILE TRAILING THE BODY IMPLANT, THE SCREWDRIVER TIP BROKE INSIDE THE BODY OF THE IMPLANT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT; ADDITIONAL DEVICES WERE USED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506352 ARCOS 3.5MM HEX DRIVE INSTRUMENT, HIP KWA ZIMMER BIOMET, INC. NI ZB110803

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10