BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X5MM HT SD X-DR SCREW

    MDR report key: 16583915 · Received March 21, 2023

    Report

    Report Number
    0001032347-2023-00068
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 20, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053741
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VISUAL INSPECTION WAS CONDUCTED ON THE THREE RETURNED SCREWS. ALL THREE SCREW SHOW SIGNS OF ATTEMPTED USING INCLUDING MARKING/ SCRATCHING ON THE SCREW HEADS. ALL THREE SCREWS HAVE FRACTURED SCREW SHAFTS. THE SCREW TIPS WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 91-6105, LOT# J935280, 1.5X5MM HT SD X-DR SCREW QTY 2. 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: 0001032347-2023-00069 AND 001032347-2023-00070.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT IS REPORTED THAT DURING A PROCEDURE WHILE PLACING A TREPHINATION PLATE WITH SCREWS, THAT THREE OF THE SCREWS FRACTURED CREATING THE NEED TO PLACE THE PLATE IN ANOTHER AREA. THERE WAS A SURGICAL DELAY AND THREE FRAGMENTS OF THE SCREWS REMAINED WITHIN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355422 1.5X5MM HT SD X-DR SCREW PLATE, BONE JEY BIOMET MICROFIXATION N/A J935280 00841036053741

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other