BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROUK SCREW - 3 0MM X 32MM

    MDR report key: 9932802 · Received April 7, 2020

    Report

    Report Number
    0001825034-2020-01434
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    July 17, 2019
    Report Date
    August 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    K160058
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. H3 OTHER TEXT : PRODUCT NOT RETURNED

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN: EVENT OCCURRED IN (B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K160058. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 PATIENT UNDERWENT A FINGER FUSION SURGERY AND WAS IMPLANTED WITH A SELF-TAPPING CANNULATED BAROUK SCREW. FOLLOWING THE SURGERY, THE PATIENT STARTED EXPERIENCING SWELLING AND PAIN AT THE TIP OF HER FINGER. X-RAY REVEALED THAT THE HEAD OF THE SCREW HAD BROKEN OFF. PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIX MONTHS POST-IMPLANTATION TO REMOVE THE BROKEN SCREW, BUT HER OPERATING SURGEON WAS ONLY ABLE TO REMOVE THE HEAD OF THE SCREW. DUE TO BONE REGROWTH, IT WAS IMPOSSIBLE TO REMOVE THE REST OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396557 BAROUK SCREW - 3 0MM X 32MM TRAUMA, IMPLANT HWC ZIMMER BIOMET, INC. N/A DLFB13

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R