BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 3.5MM HEX DRIVE

    MDR report key: 16005945 · Received December 19, 2022

    Report

    Report Number
    0001825034-2022-02804
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 28, 2022
    Report Date
    January 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304484498
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED BOTH DRIVERS EXHIBIT FRACTURED TIPS. THE DRIVERS HAVE BEEN SCUFFED SUCH THAT RINGS ARE PRESENT AROUND THE SHAFT. THE GRIPS ARE SCRATCHED. ADDITIONALLY, THE FEATURES OF THE FRACTURE SURFACE FOR BOTH HEX DRIVERS VISUALLY ALIGN WITH A TORSIONAL OVERLOAD FRACTURE FAILURE MODE WAS IDENTIFIED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 11-301415 LOT 842800 ARCOS CYL DIST. ZIMMER CAT# 30103605 LOT 65627117 G7 VIT E. CAT# 650-0660 LOT 3103617 DELTA CERAMIC FEM. CAT# 11-301303 LOT 110270 ARCOS CON STD. THE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 02805.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON PUT DOWN THE ARCOS REAL STEM IMPLANT AS THEY BEGAN TRAILING WITH THE TRIAL CONE BODY. WHEN THEY TRIED TO TAKE THE TRIAL CONE BODY OFF WITH THE SCREWDRIVER, THE SCREWDRIVER BROKE. A SECOND SCREWDRIVER BROKE IN THE PROCESS. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2709427 ARCOS 3.5MM HEX DRIVE INSTRUMENT, HIP KWA ZIMMER BIOMET, INC. N/A ZB6771570 00880304484498

    Patients

    Seq Age Sex Outcome Treatment
    1 Female