BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM

    MDR report key: 10033545 · Received May 7, 2020

    Report

    Report Number
    0001032347-2020-00230
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 17, 2020
    Report Date
    August 25, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036134808
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. A VISUAL INSPECTION CONFIRMED THAT THE TIP OF THE SCREW IS NO LONGER PRESENT. THERE WILL BE NO DHR REVIEW AS THE LOT NUMBERS REMAIN UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (91-6704) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE FRACTURING OF THIS SCREW, THERE IS A COMPLAINT RATE OF (B)(4) WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE FRACTURE IS THE APPLICATION OF EXCESSIVE FORCE BEYOND WHAT THE PRODUCT IS DESIGNED TO ENCOUNTER. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). 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. CONMITANT MEDICAL PRODUCTS: THINFLAP SYSTEM 24MM BENT BURR HOLE PLATE 30.6MM X .3MM, PART# 19-1021, LOT# NI. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE - (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW FRACTURED UPON IMPLANTATION DURING A CRANIAL PROCEDURE. A PLATE WAS ALSO SCRATCHED AT THE TIME OF THE SCREW FRACTURE. NEW PLATES AND SCREWS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498779 THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM PLATE, BONE JEY BIOMET MICROFIXATION N/A UNK 00841036134808

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE