BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5MM X 4MM

    MDR report key: 7657357 · Received July 2, 2018

    Report

    Report Number
    0001032347-2018-00425
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    May 29, 2018
    Report Date
    December 21, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE 1.5X4MM HT SD X-DRIVE SCREW (PART# 95-6104, LOT# UNKNOWN) WAS NOT RETURNED. THE CUSTOMER DID PROVIDE PHOTOS OF THE SCREW. THE SCREW APPEARED TO HAVE A DULL TIP, HOWEVER, IT COULD NOT BE DETERMINED HOW THE WHEN THE DAMAGE OCCURRED. THE CROSS DRIVE HEAD OF THE SCREW DID NOT APPEAR TO HAVE ANY NOTICEABLE DAMAGE. THE PART WAS NOT RETURNED AND THEREFORE COULD NOT BE VISUALLY EVALUATED OR FUNCTIONALLY TESTED; THEREFORE THE COMPLAINT CANNOT BE VERIFIED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IT IS POSSIBLE THAT THE SCREW WAS DAMAGED DURING AN INSERTION ATTEMPT INTO DENSE BONE. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. DEVICE EVALUATED BY MANUFACTURER AND NOT RETURNED TO MANUFACTURER.

    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). REPORT SOURCE: FOREIGN COUNTRY - (B)(6). 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE 1.5X4MM HT SD X-DR SCREW 5-PK (PART# 95-6104, LOT# UNKNOWN) WAS VISUALLY EVALUATED. THE SCREW APPEARED TO HAVE A DULL TIP. THE CROSS DRIVE HEAD OF THE SCREW DID NOT APPEAR TO HAVE ANY NOTICEABLE DAMAGE. THE SCREW WAS FUNCTIONALLY TESTED BY INSERTING IT INTO A BLOCK OF WHITE OAK WOOD USING A DRIVER AND BLADE. THE SCREW INSERTED INTO THE WOOD EASILY, THEREFORE THE COMPLAINT IS UNCONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED, BUT IT IS POSSIBLE THAT THE SCREW WAS DAMAGED DURING AN INSERTION ATTEMPT INTO HIGH-DENSITY BONE. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CRANIOTOMY PROCEDURE ONE SCREW WAS UNABLE TO BE INSERTED. THE SURGERY WAS COMPLETED WITHOUT DELAY USING ANOTHER SCREW OF THE SAME SIZE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496584 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5MM X 4MM BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1