BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMAONE SYSTEM OMNIMAX SD XD SCREW 2.0X9MM

    MDR report key: 14462664 · Received May 20, 2022

    Report

    Report Number
    0001032347-2022-00129
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 24, 2022
    Report Date
    June 2, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    DZL
    PMA / PMN Number
    K143336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: 91-5709, LOT # NI, TRAUMAONE SYSTEM OMNIMAX SD XD SCREW 2.0X9MM. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001032347-2022-00128.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED SCREW. THE SCREW SHOWS SIGNS OF ATTEMPTED USE INCLUDING MARKING ON THE SCREW HEADS. THE SCREW SHAFT HAS FRACTURES IN THE BONE THREAD SECTION. A DIMENSIONAL ANALYSIS CANNOT BE CONDUCTED DUE TO THE DAMAGE TO THE SCREW. THE COMPLAINT IS CONFIRMED. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE SCREW TO FRACTURE. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE SCREW FRACTURED. THE PATIENT RETAINED A FRAGMENT OF THE DEVICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551325 TRAUMAONE SYSTEM OMNIMAX SD XD SCREW 2.0X9MM SCREW, FIXATION, INTRAOSSEOUS DZL BIOMET MICROFIXATION N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Other