BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARROLL-GIRARD SCREW 9.5CM

    MDR report key: 14646059 · Received June 9, 2022

    Report

    Report Number
    0001032347-2022-00200
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    April 30, 2022
    Report Date
    July 8, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT UPON REDUCTION OF DISPLACED LEFT ZF FRACTURE, A CARROLL-GIRARD T BAR WAS PLACED AND THE INSTRUMENT FRACTURED UPON REDUCTION. THE END OF THE CARROLL GIRARD WAS LEFT IN THE BONY SECTION AS RETRIEVAL DOES NOT OUTWEIGH THE RISK/BENEFIT AND WILL NOT CAUSE COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23344 CARROLL-GIRARD SCREW 9.5CM SCREW HWI BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Other