BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIMAX SD XD SCREW 2.0X7MM

    MDR report key: 13579007 · Received February 22, 2022

    Report

    Report Number
    0001032347-2022-00056
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    November 10, 2021
    Report Date
    March 8, 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 # 91-5707, LOT # UNK, OMNIMAX SD XD SCREW 2.0X7MM. 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: 0001032347-2021-00534.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED SCREWS WAS FRACTURED AT THE START OF THE BONE THREAD SECTION OF THE SCREW. THE SCREWS APPEARED TO HAVE RED RESIDUE INSIDE THE BONE THREADS AND LOCKING THREADS. NO NOTICEABLE DAMAGE WAS OBSERVED ON THE CROSS-DRIVE INTERFACE. 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 THE SCREW BROKE DURING A PROCEDURE AND REMAINS IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE USING ERICH ARCH BARS. THERE WAS A FORTY FIVE (45) MINUTE DELAY WHILE THE SURGEON ATTEMPTED TO REMOVE THE SCREW. NO ADDITIONAL 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
    905260 OMNIMAX SD XD SCREW 2.0X7MM SCREW, FIXATION, INTRAOSSEOUS DZL BIOMET MICROFIXATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention SEE H10