BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTRA ANGLE TEMPORARY FIXATION SCREW

    MDR report key: 7048467 · Received November 21, 2017

    Report

    Report Number
    0001032347-2017-00817
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 21, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT ONE OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00818.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A RIB FIXATION PROCEDURE, THE BLADE (76-0017) BECAME STUCK IN THE BONE AS WELL AS IN THE DRIVER (24-1189). THE BLADE WOULD NOT RELEASE FROM THE DRIVER IN THE NORMAL MANNER. THE SURGEON WAS ABLE TO PRY THE DRIVER FROM THE BLADE (WITH THE BLADE STILL IN THE PATIENT¿S BONE), BUT WAS UNABLE TO RE-ENGAGE THE DRIVER AND BLADE SO THAT THE BLADE COULD BE BACKED OUT OF THE BONE. THE SURGEON THEN USED FORCEPS TO PULL THE BLADE FROM THE PATIENT¿S BONE. AS A RESULT, A NEW HOLE WAS MADE IN THE BONE. ANOTHER DRIVER AND BLADE WERE USED AND THE SURGERY WAS THEN COMPLETED SUCCESSFULLY. THERE WAS A THREE MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830869 CONTRA ANGLE TEMPORARY FIXATION SCREW TEMPORARY FIXATION SCREW HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention