BEUDAMED
    FDA Adverse Event Injury Summary report: N

    90 DEGREE CONTRA ANGLE DRIVER

    MDR report key: 7282413 · Received February 20, 2018

    Report

    Report Number
    0001032347-2018-00095
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 25, 2018
    Report Date
    June 4, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU TEMPORARY FIXATION SCREW CATALOG #: 76-0017 LOT #: NI. THERAPY DATE: (B)(6) 2018. 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 REPORT: 0001032347-2018-00096.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE PARTS NOT BEING RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00096-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRIVER THAT WOULD NOT RELEASE THE PIN WAS USED ON A DIFFICULT LOCATION ON THE THIRD RIB. THE SURGEON ATTEMPTED TO RELEASE THE PIN SEVERAL TIMES, BUT ULTIMATELY HAD TO PULL THE DRIVER AND PIN FROM THE BONE WHICH RESULTED IN THE BONE BEING STRIPPED. THE SECOND DRIVER THAT WAS USED WOULD NOT TURN THE SCREW. THERE WAS A DELAY OF APPROXIMATELY 10-15 MINUTES AS ANOTHER SET WAS OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP DRIVERS FROM ANOTHER SET. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128003 90 DEGREE CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention